E-ISSN:2456-3110

Research Article

Chronic Tonsillitis

Journal of Ayurveda and Integrated Medical Sciences

2022 Volume 7 Number 7 August
Publisherwww.maharshicharaka.in

A clinical study to evaluate the effect of Dashamoola Hareetaki Avaleha in Tundikeri w.s.r to Chronic Tonsillitis

Prabhu A.1*, Sharashchandra R.2, Nagaratna S.3, Kumar Shetty S.4
DOI: http://dx.doi.org/10.21760/jaims.7.7.1

1* Aiswarya Prabhu, Post Graduate Scholar, Department of PG Studies in Kaumarabhritya, Sri Dharmasthala Manjunatheswara College of Ayurveda, Udupi, Karnataka, India.

2 R Sharashchandra, Associate Professor, Department of PG Studies in Kaumarabhritya, Sri Dharmasthala Manjunatheswara College of Ayurveda, Udupi, Karnataka, India.

3 SJ Nagaratna, Associate Professor, Department of PG Studies in Kaumarabhritya, Sri Dharmasthala Manjunatheswara College of Ayurveda, Udupi, Karnataka, India.

4 Sandesh Kumar Shetty, Associate Professor, Department of PG Studies in Swasthasthavritta, Sri Dharmasthala Manjunatheswara College of Ayurveda, Udupi, Karnataka, India.

Recurrent tonsillitis is commonly seen in children and this has many adverse effects on the normal growth and development of child, missing of school days, economic burden of treatment etc. are few to name. About 30 million children develop tonsillitis with frequent exposure to bacterial and viral infections. Chronic tonsillitis wherein tonsil gland gets inflamed and enlarged repeatedly, after treatment size remains same though inflammation subsides. This leads to obstruction in throat both to airways as well as digestive tract. According to Ayurvedic classics, various internal medicines and procedures are advocated in management of Mukharogas. In general, drugs selected for treatment should have Lekhana, Shothahara, Pachana, Ropana, Rakthashambana and Vedanasthapana properties. One such polyherbal preparation is Dashamoolaharitaki Avaleha mentioned in Svayathu Chikitsa by Acharya Vagbhata, which is widely used in clinics for management of Tundikeri. In present scenario scientific validation about the success of these treatments is required. Therefore an open label clinical study was designed to prove effect of Dashamoolaharitaki Avaleha in Tundikeri. Materials and Methods: An open trial single group clinical study with minimum of 30 patients between the age group of 5 to 15 years with Tundikeri over a period of 30 days. Result: The clinical study showed highly significant results in relieving clinical signs and symptoms of Tundikeri. Discussion: The Dashamoolaharitaki Avaleha was found therapeutically effective and safe to be administered in children and mode of action was elaborated to substantiate results.

Keywords: Ayurveda, Chronic tonsillitis, Dashamoola Haritaki Avaleha, Mukharoga, Shothahara, Tundikeri

Corresponding Author How to Cite this Article To Browse
Aiswarya Prabhu, Post Graduate Scholar, Department of PG Studies in Kaumarabhritya, Sri Dharmasthala Manjunatheswara College of Ayurveda, Udupi, Karnataka, India.
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Aiswarya Prabhu, R Sharashchandra, SJ Nagaratna, Sandesh Kumar Shetty, A clinical study to evaluate the effect of Dashamoola Hareetaki Avaleha in Tundikeri w.s.r to Chronic Tonsillitis. J Ayu Int Med Sci. 2022;7(7):1-9.
Available From
https://jaims.in/jaims/article/view/1911

Manuscript Received Review Round 1 Review Round 2 Review Round 3 Accepted
2022-06-21 2022-06-23 2022-06-30 2022-07-07 2022-07-14
Conflict of Interest Funding Ethical Approval Plagiarism X-checker Note
Nil Nil Yes 18%

© 2022by Aiswarya Prabhu, R Sharashchandra, SJ Nagaratna, Sandesh Kumar Shettyand Published by Maharshi Charaka Ayurveda Organization. This is an Open Access article licensed under a Creative Commons Attribution 4.0 International License https://creativecommons.org/licenses/by/4.0/ unported [CC BY 4.0].

Introduction

Nature is the supreme mother; endlessly forgiving, endlessly resourceful and for those who acknowledge and work with her, endlessly accessible. We can work with her to maintain health and rejuvenate ourselves. As Nehru rightly said, “the children of today will make the India of tomorrow”, it is our responsibility to provide them with best care.

Ayurveda is the oldest scientific and time related rich medical science, which has been protecting the health of people from centuries. Kaumarabhritya, one among the Ashtangas of Ayurveda exclusively deals with care of children.

The human body is actually a social order of about 100 trillion cells organized into different functional structures, some of which are called organs; some organs combinedly form a system.[1] The lymphatic vasculature is not considered a formal part of the immune system, but it is critical to immunity. Even though memory CD8+ T lymphocytes outside of secondary lymphoid organs outnumber their counterparts in secondary lymphoid organs, secondary lymphoid organs remain the critical meeting point for the initiation of immune responses to antigens previously not encountered.[2] The lymphatic system consists of a fluid called lymph flowing within lymphatic vessels, several structures and organs that contain lymphatic tissue, and red bone marrow, which houses stem cells that develop into lymphocytes. Lymphatic nodules are oval shaped concentrations of lymphatic tissue. Some lymphatic nodules occur in multiple, large aggregations in specific parts of the body and one among these are the tonsils in the pharyngeal region. Usually there are five tonsils, which form a ring at the junction of the oral cavity and oropharynx and at the junction of the nasal cavity and nasopharynx. Structurally being the part of upper respiratory tract, they are strategically positioned to participate in immune responses against foreign bodies that are inhaled or ingested. Whereas their T cells destroy foreign intruders directly, B cells develop into antibody-secreting plasma cells and the antibodies dispose of foreign substances.[3] So, whenever there is an infection in the oral cavity or respiratory tract, the tonsils play first role in defense mechanism to prevent the infection.

Hypertrophied tonsils and adenoids are the major cause of upper airway obstruction in children.[4] Sore throat has an annual incidence of 100 in 1000 with tonsillitis accounting for approximately 32 in 1000 subjects per year.[5] It is also estimated that 35 million work and school days are lost per year because of sore throat. Tonsillitis is one among the disease entity that makes a child to miss his school days. About 30 million children develop tonsillitis with frequent exposure to bacterial and viral infection.[6] Chronic tonsillitis that mostly occurs due to improper management of acute condition affects the normal routine of child. If not treated it can have many complications like Peritonsillar abscess, Parapharyngeal abscess, Intratonsillar abscess, Tonsilloliths, Tonsillar cysts, focus of infection in Rheumatic fever, acute glomerulonephritis, etc. The treatment modalities for chronic tonsillitis include conservative management as well as tonsillectomy.[7]

Shalakya Tantra, one among Astangas of Ayurveda has given second most important place by Acharya Sushruta. It is that branch which is meant for alleviation of diseases of ear, eye, mouth, nose etc situated in Urdwajatru. Acharya Charaka has quoted that in a living being, head is the seat for life and all the sense facilities and therefore it is considered as Uttamanga.[8] Mukharoga is one among the diseases explained under Uttamanga. Tonsillitis can be correlated Tundikeri which is one among the Mukharogas sub classified under Talugata as well as Kantagata Rogas by Acharyas. Lot of Ayurvedic formulations are widely used in the management of chronic tonsillitis and most of them are herbal in origin. However, many of them are yet to be clinically proved and analysed statistically which is a part of present research methodology. By considering the Lakshanas of Tundikeri, Pradhanyatha of Kapha and Rakta in disease is ascertained and hence, for the Samprapti Vighatana Kapharaktahara and Shophahara treatment has to be adopted. With this intension Dashamoola Haritaki mentioned under Svayathu Chikitsa of Vagbhata is taken in view of providing symptomatic relief and reducing the recurrence of the disease.[9] The therapeutic effect of Dashamoola Haritaki in chronic tonsillitis is yet to be explored. This drug is considered for the study to avoid the surgical intervention, parental fear and permanent loss of primary defence. Thus, this clinical study is intended to explore the efficacy of Dashamoola Haritaki in children suffering from chronic tonsillitis.


Aims and Objectives

To study the efficacy of Dashamoola Haritaki Avaleha in the management of Tundikeri (Chronic Tonsillitis) in children.

Materials and Methods

Source of Data

Diagnosed cases of Tundikeri (chronic tonsillitis) are selected from OPD & IPD of SDM College of Ayurveda & Hospital, Kuthpady, Udupi.

a. Literary source: Classical textbooks of Ayurveda, text book of contemporary science are referred.

b. Clinical source: A minimum of 30 patients suffering from Tundikeri in an age group of 5 to 15years of either sex is selected and subjected to clinical trial.

c. Drug source: All the ingredients for the preparation of trial drug Dashamoola Hareetaki, is collected and prepared from GMP certified SDM Pharmacy, Udupi.

Diagnostic Criteria

The subjects will be diagnosed on the basis of clinical signs and symptoms[18,19]


  • Enlarged tonsils (Hanusandhiashrita Kathina Shopha)
  • Recurrent or persistent sore throat
  • Difficulty in swallowing and breathing
  • Irritation in throat
  • Cough
  • Halitosis
  • Jugulodigastric lymphadenopathy

Study design

  • Study type : Interventional
  • Design : Pre-test and post-test
  • Allocation : Non random
  • Endpoint classification : Efficacy study
  • Intervention model : Single group
  • Primary purpose : Treatment
  • Masking : Open label

Intervention period

30 days, subjects will be reviewed on 15th and 30th day (After completion of treatment)

Follow-Up

Follow up will be done 15 days after the completion of study

Inclusion criteria

1. Children aged between 5 to 15 years presenting with enlarged tonsils with 2 or more symptoms mentioned under the diagnostic criteria.

Exclusion criteria

1. Children suffering from acute tonsillitis.

2. Children presenting with tonsils enlarged in such a way that they are about to touch each other.

3. Children presenting with Peritonsillar abscess, Parapharyngeal abscess, Intratonsillar abscess, Tonsilloliths, Tonsillar cysts, Rheumatic fever, acute glomerulonephritis, and eye and skin disorders.

4. Children suffering from other acute & chronic systemic illness and undergoing other interventions.


Dosage form (Kalpana) Avaleha
Dose 5-10 years = 5g bd 11-15 years = 7g bd
Dosage form (Kalpana) Avaleha
Dose 5-10 years = 5g bd 11-15 years=7g bd
Time of administration Adhobhakta (After food)
Anupana Hot water
Route Oral
Duration of treatment 30 days

Assessment criteri

Subjects are assessed before and after study by observing grades of clinical signs and symptoms

Subjective parameters

1. Recurrent attacks of sore throat

2. Irritation of throat

3. Difficulty in swallowing

4. Difficulty in breathing

5. Cough

6. Halitosis

7. Hoarseness of voice



Objective parameters

1. Size of tonsil

2. Lymph node enlargement

Observations and Results

No. of patients registered for the study 32
No. of patients completed the study 30
No. of dropout 2

As per the proforma, observations were made regarding the incidence of Age, sex, occupation, religion, socio-economic status, diet, nutritional status etc.

Table 1: Distribution of 30 patients according to different criteria

Parameters Observations Maximum number of patients %
Age group 5-10 yrs 16 53.3
Gender Male 16 53.3
Socioeconomic class Lower class 12 40
Domicile Rural 21 70
Education status Primary school 17 56.7
Diet Mixed 21 70
Appetite Moderate 20 66.7
Bowel habit Regular 19 63.3
Sleep Sound 18 60
Prakriti Pitta Kaphaja 13 43.3

Table 2: Disease related observations

Parameters Observations Maximum number of patients %
Mode of onset Episodic 21 70.0
Duration of chronicity 1-2 year 10 33.3
Symmetry of enlarged tonsils Bilateral enlargement 30 100.0
Yellowish beads of pus on the medial side of the tonsil Present 21 70.0
Membranes, ulcers, mass Absent 30 100.0
Palpation of tonsils Palpable 26 86.7

Table 3: Signs and symptoms

Parameters Observations Maximum number of patients %
Recurrent attack of sore throat Present 30 100.0
Irritation of throat Present 29 96.7
Difficulty in swallowing Present 20 66.7
Mouth breathing / difficulty of breathing Present 17 56.7
Cough Present 25 83.3
Halitosis Absent 20 66.7
Hoarseness of voice Absent 20 66.7

Results

Table 4: Effect of treatment on objective parameters.

Parameters Negative ranks Positive ranks Tie Z value P value Interpretation
N MR SR N MR SR
Size of tonsils
BT-AT 30 15.50 465.00 0 .00 .00 0 -5.305 .000 HS
BT-FU 30 15.50 465.00 0 .00 .00 0 -4.983 .000 HS
Jugulodigastric lymphadenopathy
BT-AT 29 15.50 435.00 0 .00 .00 0 -5.231 .000 HS
BT-FU 29 15.50 435.00 0 .00 .00 0 -5.231 .000 HS

Table 5: Effect of treatment on subjective parameters.

Parameters Negative ranks Positive ranks Tie Z value P value Interpretation
N MR SR N MR SR
Recurrent attacks of sore throat
BT-AT 30 15.50 465.00 0 .00 .00 0 -4.983 .000 HS
BT-FU 30 15.50 465.00 0 .00 .00 0 -4.983 .000 HS
Irritation of throat
BT-AT 27 14.00 378.00 0 .00 .00 0 -4.786 .000 HS
BT-FU 28 14.50 406.00 0 .00 .00 0 -4.774 .000 HS
Difficulty in swallowing
BT-AT 22 11.50 253.00 0 .00 .00 0 -4.523 .000 HS
BT-FU 22 11.50 253.00 0 .00 .00 0 -4.456 .000 HS
Halitosis
BT-AT 12 6.50 78.00 0 .00 .00 0 -3.276 .001 HS
BT-FU 12 6.50 78.00 0 .00 .00 0 -3.276 .001 HS
Mouth breathing/difficulty of breathing
BT-AT 15 8.00 120.00 0 .00 .00 1 -3.873 .000 HS
BT-FU 16 8.50 136.00 0 .00 .00 0 -3.900 .000 HS
Cough
BT-AT 25 13.00 325.00 0 .00 .00 1 -4.507 .000 HS
BT-FU 25 13.00 325.00 0 .00 .00 0 -4.490 .000 HS
Hoarseness of voice
BT-AT 11 6.00 66.00 0 .00 .00 0 -3.317 .001 HS
BT-FU 11 6.00 66.00 0 .00 .00 0 -3.317 .001 HS

Clinical study was conducted at SDM Ayurveda Hospital, Udupi. Among 32 patients registered for the study, 30 patients who completed the study were assessed before the treatment (BT), on 30th day (AT) and after 15 days of follow up on the 45th day (AF). Different parameters were assessed based on the grading given to those symptoms. They were recorded in the case proforma. Then finally, relevant statistical tests were applied to check the significance.


Wilcoxon signed rank test is used to assess BT, AT and AF values of the individual group as the data is categorical (ordinal). The numerical data was tested using paired‘t’ test. The analysis is done statistically using Statistical Package for Social Science (SSPS) version 2.0.

Different symptoms, investigations assessed in the patients and their results are as follows;

All the subjective and objective parameters showed highly significant results which discloses that the study drug is effective in reducing the signs and symptoms of chronic tonsillitis

Discussion

Discussion on the probable mode of action of drug

The major drugs used in the preparation of the Dashamoola Haritaki Leha are primarily Ushna Veerya, alongside a few Sheeta Veerya drugs. In the formulation of the Dashamoola Haritaki Rasayana, Tikta Katu Madhura and Kashaya is the dominant Rasa, Laghu Ruksha and Tikshna Gunas are the major Gunas, with only a few Guru, Picchila and Snigdha of the individual herbs.

Laghu Guna does Lekhana and Ropana.[10] Tikshna Guna does Sodhana & Kaphavatahara Karma[11] acts as antagonists to Kapha Gunas thereby normalizing Kapha. Ruksha Guna does Soshana[12] and is Kaphahara in action.[13]

Kashaya Rasa relieves Pitta and Kapha disorders along with the effects of Sodhana[14] while Katu Rasa combats the Kapha, clears the obstruction in the Srotas, and accomplishes Sodhana.[15]Tikta Rasa owns the Kanta-Sodhana and Lekhana property.[16]The majority of the Dravyas in Dashamoola Haritaki Leha are Tridosha Samakas and Pittakapha pacifying in nature.

So, all these factors helps in reversing the pathophysiology of Tundikeri.

Discussion on results

Effect of Dashamoola Haritaki Avaleha on size of tonsils

When size of tonsils was compared before treatment to after treatment, z value was -5.305 and p value was 0.000, thus results are statistically highly significant. When compared before treatment

to after follows up, z value was -4.983 and p value was 0.000 showing statistically highly significant. It shows progressive reduction in size of enlarged tonsils.

Most of the drugs in the study drug is Shothahara in action and the Dashamoola Haritaki Avaleha is the specific formulation told by Acharya Vagbhata for Pravritha Shopha.[17] The main ingredients Dashamoola and Haritaki, known for its anti-inflammatory properties helps in reducing the inflammation in the tonsillar tissues. This implies that the trial drug was very effective in reducing the size of tonsils and further retained the effect during the follow-up period.

Effect of Dashamoola Haritaki Avaleha on Jugulodigastric lymphadenopathy

When Jugulodigastric lymphadenopathy compared before treatment (mean 1.13) to after treatment (mean 0.06) with Wilcoxon signed rank test, z value was -5.231 and p value was 0.000 which is statistically highly significant. When size of tonsils compared before treatment (mean 1.13) to after follow-up (mean 0.06) with Wilcoxon signed rank test, z value was -5.231 and p value was 0.000 which is statistically highly significant.

By checking the phyto-constituents Dashamoola Haritaki Avaleha is best analgesic and anti-inflammatory. Dashamoola, one among the main ingredient of study drug has consistently shown efficacy in models of inflammation hinted at the possibility of prostaglandin synthesis inhibition as the probable mechanism of action.[18]

Thus reduction in the inflammatory changes of tonsillar tissues in turn facilitates reduction in the local lymphadenopathy.

Effect of Dashamoola Haritaki Avaleha on recurrent attack of sore throat

When recurrent attacks of sore throat compared before treatment (mean 1.36) to after treatment (mean 0.03) with Wilcoxon signed rank test, z value was -4.983 and p value was 0.000 which is statistically highly significant. When recurrent attacks of sore throat compared before treatment (mean 1.36) to after follow-up (mean 0.03) with Wilcoxon signed rank test, z value was -4.983 and p value was 0.000 which is statistically highly significant.


The main ingredient, Haritaki is known for its wide range of pharmacological action mainly antioxidant and immunomodulatory[19] and a potent Rasayana drug along with other antimicrobial drugs might have increased the immune status thereby preventing further attacks of infections.

Effect of Dashamoola Haritaki Avaleha on irritation of throat

When irritation of throat compared before treatment (mean 1.57) to after treatment (mean 0.35) with Wilcoxon signed rank test, z value was -4.786 and p value was 0.000 which is statistically highly significant. When irritation of throat compared before treatment (mean 1.57) to after follow-up (mean 0.14) with Wilcoxon signed rank test, z value was -4.786 and p value was 0.000 which is statistically highly significant.

Most of the drugs in the trial drug is Shothahara, Vedanasthapana and Lekhana property helps to clear the Srotas and thereby relieving irritation of throat.

Effect of Dashamoola Haritaki Avaleha on difficulty in swallowing

When difficulty of swallowing compared before treatment (mean 1.13) to after treatment (mean 0.04) with Wilcoxon signed rank test, z value was -4.523 and p value was 0.000 which is statistically highly significant. When difficulty of swallowing compared before treatment (mean 1.13) to after treatment (mean 0.00) with Wilcoxon signed rank test, z value was -4.456 and p value was 0.000 which is statistically highly significant.

Difficulty in swallowing is due to enlarged and inflamed tonsillar tissues. The anti-inflammatory action of trial drug might have helped in reduction of difficulty in swallowing.

Effect of Dashamoola Haritaki Avaleha on halitosis

When halitosis compared before treatment (mean 1.25) to after treatment (mean 0.08) with Wilcoxon signed rank test, z value was -3.276 and p value was 0.001 which is statistically highly significant. When halitosis compared before treatment (mean 1.25) to after follow-up (mean 0.08) with Wilcoxon signed rank test, z value was -3.276 and p value was 0.001 which is statistically highly significant.

The antimicrobial[20] and antibacterial[21]

properties of drugs helps to reduce the breeds of microbes in oral cavity and the Kaphahara and Srotoshodhana action of drugs helps in removing accumulated Doshas in oral cavity and thereby providing Vaktrashodhana.

Effect of Dashamoola Haritaki Avaleha on difficulty of breathing

When mouth breathing/difficulty of breathing compared before treatment (mean 1.12) to after treatment (mean 0.18) with Wilcoxon signed rank test, with z value was -3.873 and p value was 0.000 which is statistically highly significant. When mouth breathing/difficulty of breathing compared before treatment (mean 1.12) to after follow up (mean 0.06) with Wilcoxon signed rank test, z value was -3.900 and p value was 0.000 which is statistically highly significant.

Difficulty in the breathing is due to the narrowing and obstruction of upper airway due to enlarged tonsils. The Shothahara, Vedanasthapana, Srotoshodhana action of drug has helped in reduction of size of enlarged tonsils which in turn reduced the difficulty of breathing by clearing the airway.

Effect of Dashamoola Haritaki Avaleha on cough

When cough compared before treatment (mean 1.56) to after treatment (mean 0.08) with Wilcoxon signed rank test, z value was -4.507 and p value was 0.000 which is statistically highly significant. When cough compared before treatment (mean 1.56) to after follow up (mean 0.00) with Wilcoxon signed rank test, z value -4.490 and p value 0.000 which is statistically highly significant.

The drugs such as Kantakari, Brihati, Haritaki, Ela, Pippali have action on Pranavaha Srotas[22] and Kasahara effect of Yoga might have reduced the bouts of cough.

Effect of Dashamoola Haritaki Avaleha on hoarseness of voice

When cough compared before treatment (mean 1.00) to after treatment (mean 0.00) with Wilcoxon signed rank test, z value was -3.317 and p value was 0.001 which is statistically highly significant. When cough compared before treatment (mean 1.00) to after follow-up (mean 0.00) with Wilcoxon signed rank test, z value was -3.317 and p value was 0.001 which is statistically highly significant.


The ingredients of this Yoga have action on Pranavaha Srotas and also on Udanavayu which in turn bring Vakshuddi[23] thereby resulting in improving hoarseness of voice.

Effect of Dashamoola Haritaki Avaleha on weight

The mean score of weight before treatment is 30.85 and mean score after treatment is 30.90, the mean difference among the two being 0.04kg which shows that there is a 0.12 % improvement seen in weight, which is statistically highly significant with p value 0.000.

The Deepana Pachana effect of Yoga might have increased Agni and on relief from difficulties of deglutition combinedly enhanced the dietary intake resulting in the increase of weight.

Conclusion

Tonsillitis is a most common ailment in school going children coming about from Pharyngitis. Considering the paediatric age group, the most probable type of tonsillitis is chronic tonsillitis due to recurrent respiratory tract infections and pharyngitis. The clinical features of chronic tonsillitis can be potentially correlated to Tundikeri Lakshanas explained by Vagbhata. Most of the Aharaja Nidanas like Guru, Abhishyandi Aharas and Viharas like Avakshayya and exposure to Raja-dhuma Atapa etc. leads to Kapha Pitta prakopa and does Sthanasamshraya in Kanta Pradesha giving rise to disease Tundikeri. Factors like poor oral hygiene, excessive intake of cold items etc. can be considered as predisposing factors for tonsillitis. Out of 30 subjects, all subjects had recurrent attacks of sore throat and enlarged tonsils.

Majority of subjects had irritation of throat, difficulty in swallowing, difficulty in breathing, cough, where a smaller number of patients had halitosis and hoarseness of voice. Classics have mentioned both surgical and nonsurgical treatment for Tundikeri. By looking into treatment modalities, we can say that the drugs which are having Lekhana, Shothahara, Shulahara, Deepana, Pachana properties should be administered in Tonsillitis.

The present study revealed that Dashamoola Haritaki Avaleha having Dashamoola and Haritaki as main ingredient along with Yavakshara and other drugs, with its anti-inflammatory,

analgesic and antimicrobial action helps in reducing the inflammation of tonsillar tissue resulting in reduction of signs and symptoms. Clinically study drug is more effective in reducing the symptoms like cough, irritation of throat and reduction in attacks of sore throat. No adverse reactions were observed in the study; therefore, it is found to be safe for pediatric age group.

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