E-ISSN:2456-3110

Research Article

Badhirya

Journal of Ayurveda and Integrated Medical Sciences

2023 Volume 8 Number 2 February
Publisherwww.maharshicharaka.in

A comparative clinical trial to evaluate the efficacy of Dashamoola Taila Karnapoorana and Nasya and orally Dashamoola Ghrita in Badhirya (sensory neural hearing loss)

Shashikala K.1*, Gururaj N.2, Hiremath V.3
DOI: http://dx.doi.org/10.21760/jaims.8.2.7

1* K Shashikala, Associate Professor, Department of PG & Ph.D Studies in Shalakya Tantra, Shree Jagadguru Gavisiddeshwara Ayurveda Medical College, Gavimath campus, Koppal, Karnataka, India.

2 N Gururaj, Associate Professor, Department of PG & Ph.D Studies in Shalakya Tantra, Shree Jagadguru Gavisiddeshwara Ayurveda Medical College, Gavimath campus, Koppal, Karnataka, India.

3 Veerayya Hiremath, Professor & HOD, Department of PG & Ph.D Studies in Shalakya Tantra, Shree Jagadguru Gavisiddeshwara Ayurveda Medical College, Gavimath campus, Koppal, Karnataka, India.

It is estimated that by 2050 over 900 million people will have disabling hearing loss. In Ayurveda hearing loss is described as Badhirya, which can be treated with Nasya, Karna Poorana, oral administration of Vatahara Ghrita and other Vatashamana procedures. This is a randomized comparative clinical study of 3 groups with 30 patients in each; namely Group-A of Dashamoola Taila Karnapoorana, Group-B of Dashamoola Taila Nasya & Group C of Dashamoola Taila Karnapoorana and Dashamoola Taila Nasya. Dashamoola Ghrita was advised for oral administration to all groups. Total Treatment duration was of 210 days i.e., 7 days (Day 1-7), followed by 48 days administration of Ghrita (Day 22-70) and follow up after 140 days. There was mild improvement in hearing in both ears with slight improvement in pure tone audiometric values. There was clinical improvement seen in all three groups, group C has better results compared to other two groups. Statistically there is significant result within the group and no statistical significance between the groups. Since, combined treatment using Dashamoola Taila Nasya and Karnapoorana and Dashamoola Ghrita orally has shown better results, following complete Chikitsasutra would be helpful in management of Badhirya than treating with single line of treatment.

Keywords: Badhirya, Dashamoola Taila, Dashamoola Ghrita, SNHL, Nasya, Karnapoorana

Corresponding Author How to Cite this Article To Browse
K Shashikala, Associate Professor, Department of PG & Ph.D Studies in Shalakya Tantra, Shree Jagadguru Gavisiddeshwara Ayurveda Medical College, Gavimath campus, Koppal, Karnataka, India.
Email: 		K Shashikala, N Gururaj, Veerayya Hiremath, A comparative clinical trial to evaluate the efficacy of Dashamoola Taila Karnapoorana and Nasya and orally Dashamoola Ghrita in Badhirya (sensory neural hearing loss). J Ayu Int Med Sci. 2023;8(2):46-53.
Available From
https://jaims.in/jaims/article/view/2279

Manuscript Received Review Round 1 Review Round 2 Review Round 3 Accepted
2023-01-02 2023-01-03 2023-01-10 2023-01-17 2023-01-24
Conflict of Interest Funding Ethical Approval Plagiarism X-checker Note
Nil yes Yes 19%

© 2023by K Shashikala, N Gururaj, Veerayya Hiremathand 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].

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Introduction

The high burden of deafness globally and in India is largely preventable and avoidable. Over 5% of the world’s population or 466 million people have disabling hearing loss (432 million adults and 34 million children). It is estimated that by 2050 over 900 million people or one in every ten people will have disabling hearing loss. Disabling hearing loss refers to hearing loss greater than 40 decibels (dB) in the better hearing ear in adults and a hearing loss greater than 30 dB in the better hearing ear in children. The majority of people with disabling hearing loss live in low- and middle-income countries.[1]

Nationwide disability surveys have estimated hearing loss to be the second most common cause of disability.[2]

Sensorineural hearing loss (SNHL) is a type of hearing loss or deafness, in which the root cause lies in the inner ear or sensory organ (cochlea and associated structures) or the vestibulocochlear nerve (cranial nerve VIII). SNHL accounts for about 90% of reported hearing loss. SNHL is generally permanent and can be mild, moderate, severe, profound, or total.

Treatment modalities fall into three categories: pharmacological, surgical, and management. As SNHL is a physiologic degradation and considered permanent, there are as of this time, no approved or recommended treatments. Pharmacological treatment options are very limited and clinically unproven. Surgeries like cochlear implants; because of risk and expense are reserved for cases of severe and disabling hearing impairment. Management of sensorineural hearing loss involves employing strategies to support existing hearing such as lip-reading, enhanced communication etc. and amplification using hearing aids. Hearing aids are specifically tuned to the individual hearing loss to give maximum benefit.[3]

In Ayurveda hearing loss is described as Badhirya, which can be treated with Nasya, Karnapoorana, oral administration of Vatahara Ghrita and other Vatahara procedures.[4]

Hence this study is emphasised on finding medical management of Badhirya (SNHL) through Karna Poorana and Nasya using Dashamoola Taila[5] and Dashamoola Ghrita Pana.

Aims and Objectives

1. To evaluate the effect of Dashamoola Taila Karna poorana and oral administration of Dashamoola Ghrita on Badhirya.

2. To evaluate the effect of Dashamoola Taila Nasya and oral administration of Dashamoola Ghrita on Badhirya.

3. To evaluate the combined effect of Dashamoola Taila Nasya and Karnapurana with oral administration of Dashamoola Ghrita on Badhirya.

Materials and Methods

Source of Data

  • Subject selected incidentally from the OPD of Shree Jagadguru Gavisddheshwara Ayurveda Medical College and Hospital, Gavimath campus, Koppal.
  • Specific proforma was prepared for the documentation of the data. Subjects were registered for the study after taking written informed consent.

Inclusion Criteria
1. The cases with features mentioned in Badhirya (sensory neural hearing loss only) irrespective of gender, caste, religion, socioeconomic status and chronicity were included.

2. Cases of Badhirya (sensory neural hearing loss only) with age > 10 years and < 70 years were selected.

Exclusion Criteria
1. Congenital sensorineural hearing loss.

2. Perforated tympanic membrane.

Diagnostic Criteria

  • Clinical features of Badhirya (sensory neural hearing loss)
  • Reduced hearing with positive Rinne’s test.

Investigations

  • PTA

Study Design

  • It was a randomized comparative clinical study.
  • A total 90 cases of Badhirya were included for the study and allocated into three groups namely Group-A, Group-B & Group C with 30 patients in each group.

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Intervention

Table 1: Showing groups, drugs, dosage, duration and route of administration.

Group Drug Route of administration Dosage Duration
A Dashamoola Taila Karna Poorana 5ml 7 days (Day 1-7)
Dashamoola Ghrita Oral administration 10ml 48 days (Day 22-70)
B Dashamoola Taila Nasya Karma 5ml 7 days (Day 1-7)
Dashamoola Ghrita Oral administration 10ml 48 days (Day 22-70)
C Dashamoola Taila Karna Poorana 5ml 7 days (Day 1-7)
Dashamoola Taila Nasya Karma 5ml 7 days (Day 1-7)
Dashamoola Ghrita Oral administration 10ml 48 days (Day 22-70)

Preparation of trial drugs

  • The drugs procured from market were authenticated from Dravya Guna department of SJGAMC Koppal.
  • The authenticated drugs used and Dashamoola Taila and Ghrita were prepared using standard preparation method in RSBK pharmacy of SJGAMC Koppal and packaging was done in aseptic measures and labeled.
  • The Prepared Drugs were analyzed at Sri Dharmasthala Manjunatheshwara Centre for Research in Ayurveda and Allied Sciences, Udupi.

Criteria for Assessment: Subjective and objective parameter were assessed on day 1 (baseline – before treatment) and day 70 (after treatment) and day 210 (follow-up).

Table 2: Showing World Health Organization Grades of Hearing Impairment (WHO, 2008)[6]

Grade of impairment Corresponding audiometric ISO value Performance
0 - No impairment 25 dB (better ear) No or very slight hearing problems. Able to hear whispers.
1 - Slight impairment 26-40 dB (better ear) Able to hear and repeat words spoken in normal voice at 1 meter.
2 - Moderate impairment 41-60 dB (better ear) Able to hear and repeat words spoken in raised voice at 1 meter.
3 - Severe impairment 61-80 dB (better ear) Able to hear some words when shouted into better ear.
4 - Profound impairment including deafness 81 dB or greater (better ear) Unable to hear and understand even a shouted voice.

Statistical methods: ‘t’ test, Anova test and Tuckey’s HSD test were applied using R Programming software.

Results

Table 3: Statistical analysis table between the groups (BT-AT)

Parameter Mean SD f-ratio P Remarks
Reduced hearing RT A 0.2 A 0.40 2.450 0.0921 N.S
B 0.33 B 0.47
C 0.46 C 0.50
LT A 0.2 A 0.40 1.016 0.366 N.S
B 0.3 B 0.46
C 0.36 C 0.49
PTA RT A 3.70 A 3.35 0.196 0.822 N.S
B 3.75 B 2.66
C 4.18 C 3.62
LT A 2.81 A 3.08 1.16 0.31 N.S
B 4.01 B 3.11
C 3.61 C 3.11

The mean difference of parameter reduced hearing (RT) for Group A is 0.2, Group B is 0.33 and Group C is 0.46 with SD for Group A is 0.40, Group B is 0.47, and Group C is 0.50. There is no significant difference between the groups in terms of reduced hearing (RT) (f=2.450, p=0.0921).

The mean difference of parameter reduced hearing (LT) for Group A is 0.2, Group B is 0.3 and Group C is 0.36 with SD for Group A is 0.40, Group B is 0.46, and Group C is 0.49. There is no significant difference between the groups in terms of reduced hearing (LT) (f=1.016, p=0.366).

The mean difference of parameter PTA (RT) for Group A is 3.70, Group B is 3.75 and Group C is 4.18 with SD for Group A is 3.35, Group B is 2.66, and Group C is 3.62. There is no significant difference between the groups in terms of PTA (RT) (f=0.196, p=0.822).

The mean difference of parameter PTA (LT) for Group A is 2.81, Group B is 4.01 and Group C is 3.61 with SD for Group A is 3.08, Group B is 3.11, and Group C is 3.11. There is no significant difference between the groups in terms of PTA (LT) (f=1.16, p=0.31).

Table 4: Tuckey’s HSD Test (BT & AT)

Parameter HSD Q value P value Remarks
Reduced hearing (LT) A:B=0.37 3.97 0.016 S
A:C=0.27 2.88 0.108 N.S
B:C=0.10 0.10 0.725 N.S

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Graph 1: Bar graph representing mean differences of BT and AT between the groups.

The simple bar graph is used to represent the difference of means between the groups for BT and AT. The parameter reduced hearing (RT) is having mean differences 0.2 for group A, 0.33 for group B and 0.46 for group C. Similarly reduced hearing (LT) is having the mean differences 0.2 for group A, 0.3 for group B and 0.36 for group C. Group A is having least mean 0.2 for reduced hearing where as group C is having highest mean 0.46 for reduced hearing (RT) and 0.36 for reduced hearing (LT).

The simple bar graph is used to represent the difference of means between the groups for BT and AT. The parameter PTA (RT) is having mean differences 3.7 for group A, 3.75 for group B and 4.18 for group C. Similarly PTA (LT) is having the mean differences 2.81 for group A, 4.01 for group B and 3.61 for group C. Group A is having least mean 3.7 and 2.81 for PTA (RT) and PTA (LT) respectively. Whereas group C is having highest mean 4.18 for PTA (RT) and group B is having highest mean 4.01for PTA (LT).

Discussion

The study was a comparative clinical trial to compare the effect of Dashamoola Taila Nasya with Dashamoola Taila Karnapoorana in the management of Badhirya with special reference to Sensorineural Hearing Loss which presents with mild to severe degree of Hearing impairment based on Audiometric values.

Discussion on results

There is a statistically significant result in treatment of impaired hearing in all 3 groups within the group.

The results between the groups were statistically insignificant. Group C showed better improvement in the symptoms Compared to other 2 groups. Among Group A and B, Group B treated with Nasya using Dashamoola Taila and Dashmoola Ghrita orally showed better improvement compared to Karnapoorana with same in group A.

Probable mode of action of Dashamoola Ghrita

The Dashamoola Ghrita was formulated on the basis of Karna Roga Samanya Chikitsa[7] (common line of treatment) i.e. ...Ghritapana Rasayanam... which means Karna Rogas can be treated very well with oral administration of Vatahara Rasayana Dravya and Ghrita Pana.

The ingredients of Dashamoola Ghrita are Dashamoola and Go-Ghrita. Dashamoola has Madhura, Tikta and Kashaya Rasa. It is Dhatuposhaka and Tridoshahara. It is also a Rasayana.[8] It is thus recommended for general weakness, neuropathy, nervine weakness and as well as to boost the immune system.

Ingredients of Dashamoola are rich in sitosterols, flavonoids and glycosides that normalize the status of the neuroendocrine system by regulating the function of important hormones. It has a powerful antioxidant effect. It is a rich tonic that stimulates the nervous system.[9] This Ayurvedic medication has following indications including Balya (increase strength), Amanashak (removes toxins), Svashahara (treats asthma), Deepana (enhances stomach fire), Pachana (helps in digestion), Rochana (stimulates appetite), Kantya (relieves sore throat), Kapha-Vatahara (treats Kapha and Vata imbalances), Rasayani (rejuvenates the whole body), Shothahara (treats pain and inflammation).[10]

Go Ghrita has the properties, Rasa: Madhura. Guna: Snigdha, Guru. Veerya: Sheeta. Vipaka: Madhura. Karma: Medhya, Agnivardhaka. It promotes memory, intelligence, Ojas and alleviates Vata and has special feature “Samskarasaya anuvartanat”- carries and enhances the properties of drugs processed with it. Ghee contains 8% lower saturated fatty acids which makes it easily digestible. Due to having 4-5% linoleic acid, an essential fatty acid, it promotes proper growth of human body. Ghee also contains vitamin A, B, E and K. Vitamin A and E are antioxidant in nature and are helpful in preventing oxidative injury to the body.


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Ghee also improves digestibility of other component, mineral absorption from diet. Cow Ghee increases the retention of calcium up to 45% and phosphorus up to 57% (kehar 1956, steggarada 1951). As chemically Ghrita consists of phospholipids, fatty acids etc., it is helpful in correcting the altered disturbed neurotransmitter. Ghrita fortified with Medhya drugs releases the Medhya effect of the drugs at neurotransmitter working place (synaps etc.). According to Russian Scientist Servos, Cow’s ghee has immense power to protect human body from the ill effect of radioactive waves.[11]

Hence, Dashamoola Ghrita by virtue of properties of its individual drugs is Vatashamaka, Shotha Hara and Rasayana in nature. Hence, Badhirya being a Vata dominant disease with Shoshana as type of Vikriti, has responded well to Dashamoola Ghrita which is best Vatahara, Balya and Rasayana in nature.

Probable mode of action of Dashamoola Taila

Dashamoola Taila was selected for the present study because it has been referred to as “Parama Aushadha” for Badhirya by Acharya Chakrapani.[12]

The ingredients of Dashamoola Taila are Dashamoola and Tila Taila.

Tila Taila has the properties like, Rasa - Madhura, kashaya, Tikta, Katu. Vipak - Madhura, Virya – Ushna. Guna - Suksma, Guru, Sara, Deepana, Lekhana, Balya Action on Dosha - Alleviates Tridosha. It nourishes and strengthens all the Dhatus, checks Dhatukshaya, and thus alleviates Vata. Snigdha and Guru Guna decreases Rukshata of Vataand with the help of Ushna Guna and Veerya it alleviates Vata.[13] The Vyavayi, Vikashi Guna of Tila Taila helps better absorption of the oil prepared with Tila Taila as the base. Tila Taila is considered as a Shreshta Vatahara. It is described as “Vataghneshu Uttamam” and “Na shleshmabhi Vardhana” by Charaka.[14]

Tila Taila is rich in minerals like Calcium and zinc that are good for bones, that act on ossicles and mastoid bone, Magnesium supports respiratory and vascular health that act on middle ear mucosa and improves blood circulation pertaining to ear. Alkaloids are central nervous system stimulants. Flavonoids and phenols give it antioxidant properties also saponins which are antioxidant.

It has two components Sesamin and Sesamolin. Sesamin is also known to protect neuronal cells against oxidative stress and it exhibits anti-inflammatory and anti-allergic effects. These components help in scavenging ROS (Reactive Oxygen Species) and thus prevent damage to the neuronal cells during degenerative phase. Thus, these antioxidants have the potential to protect cells from oxidative damage.[15]

Hence, Badhirya being a Vata dominant disease has responded well to Dashamoola Taila treatment which is best Vatahara & Balya in nature.

Discussion on Probable mode of action of therapeutic procedure

Mode of action of Poorva Karma: Sthanika Abhyanga and Sweda facilitates drug absorption through nasal mucosa, nasal neuron and para nasal sinuses.[16],[17] Nasal epithelium consists of tightly packed cell line. Abhyanga and Sweda results in facial efferent stimulation in turn reflecting as 22% dilation in capillaries which is benefitting by 150% increase in blood flow and allowing better passage of drug.[18] Same can be applied to mode of action of Karnapoorana also.

Mode of action of Nasya Karma: In Ashtanga Sangraha, Nasa is described as the gateway of Shirah. Hence, the drug is administered through nostrils reaches the Shringataka (Sira Marma) and spreads in Murdha (brain) reaching the Marmas of Netra, Shrotra, Kantha and Shiramukha. It then by virtue of its potency scratches the morbid Dosha in supraclavicular region and expels them from Uttamanga.[19]

Nasal mucosa is the only location in the body that provides a direct connection between CNS and the atmosphere.[20] Drugs administered to the nasal mucosa rapidly traverse through the cribriform plate into the CNS by three routes: (1) directly via the olfactory neurons, (2) through supporting cells and the surrounding capillary bed, and (3) directly into the cerebrospinal fluid.[21]

Mode of action of Karnapoorana: Cells in many tissues are protected from stress-induced apoptosis by the activation of heat shock proteins (HSPs). This protective effect is mediated at least in part by the chaperone activity of HSPs and by direct inhibition of apoptotic signaling pathways. In the inner ear, activation of the heat shock response


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improves the survival of hair cells exposed to ototoxic drugs.[22] Similar action is brought about by the heat of medicine used in Karnapoorana. The heat generated by the warm oil after instillation causes pseudo congestion of vessels of tympanic membrane and thus enhancing drug entry into middle ear. Animal experiments show that the Round Window Membrane behaves like a semipermeable membrane. The permeability of the RWM can be influenced by the factors such as size, configuration, concentration, liposolubility and electrical charge of the substance, and the thickness and the condition of the RWM,[23] thus probably absorbed oil from round window membrane nourishes the nerve terminals and thereby preventing degeneration.

Conclusion

Dashamoola Taila, Dashamoola Ghrita were administered to the patients in respective groups, according to the protocol approved by Advanced Research wing of Rajiv Gandhi University of Heath Sciences, Bengaluru. Observations were recorded in case proforma specially prepared for the study. Results were drawn statistically by using ‘t’ test, Anova test and Tuckey’s HSD test. Combined treatment using Dashamoola Taila Nasya and Karnapoorana and Dashamoola Ghrita orally has shown better results. Hence following complete Chikitsa Sutra (complete protocol) would be helpful in management of Badhirya than treating with single line of treatment (any one treatment from protocol).

Financial support: This study was carried out with the Financial support and sponsorship from Faculty Research Grant by Advanced Research Wing of Rajiv Gandhi University of Health Sciences, Karnataka, Bengaluru.

Acknowledgement: Dr. B. S. Savadi, Principal, Dr. S. S. Shirurmath, HOD Dravyaguna, Dr. Rudrakshi P D, RSBK Pharmacy In charge, Dr. Raju S N, Dr Remya Madhav, Assistant professors, office staff and all supporting staff of SJGAMC office.

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