E-ISSN:2456-3110

Research Article

Clinical Trial

Journal of Ayurveda and Integrated Medical Sciences

2021 Volume 6 Number 1 Jan-Feb
Publisherwww.maharshicharaka.in

Clinical study to evaluate the efficacy of Madhutailika Basti in the management of Madhumehajanya Nadiprathan Shotha w.r.t. Diabetic Neuropathy

Pathak M.1*, Mhatre A.2
DOI: 10.21760/jaims.6.1.3

1* Mridula Pathak, Post Graduate Scholar, Dept. of Kayachikitsa, D. Y. Patil School of Ayurveda, Navi Mumbai, Maharashtra, India.

2 Ashish Mhatre, Associate Professor, Dept. of Kayachikitsa, D. Y. Patil School of Ayurveda, Navi Mumbai, Maharashtra, India.

Aim and Objectives: To evaluate clinical efficacy of Madhutailika Basti in the management of Madhumehajanya Nadipratan Shotha w.r.t. Diabetes Neuropathy. Methodology: A total of 30 subjects were selected from the OPD and IPD of Dr. D.Y. Patil College of Ayurveda, Research Institute and Hospital. The patients were assessed according to case report form for the duration of 30 days. In present study the reassessment of Madhutailika Basti has been done to understand its efficacy in Diabetic Neuropathy. Madhutailika Basti, contains Madhu, Erandamool Kwatha, Til Taila, Shatapushpa Kalka, Saindhava Lavana. Conclusion: The improvement was calculated by subjective parameters like Prabhutavil Mutrata (polyurea), Kshudha Vruddhi (polyphasia), Pippasa Vruddhi (polydipsia), Dourbalya (general weaknesss), Paridaha (burning sensation), Kandu (itching), Bhrama (vertigo), Anidra (insomnia), Nakta Mutra Pravrutti (urination during night), Hast Pada Chimchimaya (tingling) to score clinical outcome is indicated in the Management of neuropathic pain associated with diabetic neuropathy. Madhutailika Basti presents window of opportunity in the clinical management of Diabetic Neuropathy.

Keywords: Diabetic Neuropathy, Madhutailika Basti, Madhumehajanya Nadipratan Shotha

Corresponding Author How to Cite this Article To Browse
Mridula Pathak, Post Graduate Scholar, Dept. of Kayachikitsa, D. Y. Patil School of Ayurveda, Navi Mumbai, Maharashtra, India.
Email: 		Mridula Pathak, Ashish Mhatre, Clinical study to evaluate the efficacy of Madhutailika Basti in the management of Madhumehajanya Nadiprathan Shotha w.r.t. Diabetic Neuropathy. J Ayu Int Med Sci. 2021;6(1):16-23.
Available From
https://www.jaims.in/index.php/jaims/article/view/1176

Manuscript Received Review Round 1 Review Round 2 Review Round 3 Accepted
2021-01-01 2021-01-12 2021-01-17 2021-01-24 2021-02-17
Conflict of Interest Funding Ethical Approval Plagiarism X-checker Note
Nil Nil Yes 8%

© 2021 by Mridula Pathak, Ashish Mhatre and 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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Mridula Pathak et al. Efficacy of Madhutailika Basti in Madhumehajanya Nadiprathan Shotha

Introduction

Diabetic peripheral neuropathy is a nerve damaging disorder associated with diabetes mellitus. Diabetic microvascular injuries involving small blood vessels that supplies to nerves i.e., Vasa nervorum are responsible for diabetic peripheral neuropathy.

In Ayurveda, Madhumeha Vyadhi has similarity with Diabetes Mellitus. Madhumeha is one of the four varieties of Vataja Prameha. It is Asadhya (incurable) stage, Madhumeha gives rise to many Upadrava (complication) viz. Daha (burning sensation), Suptata (numbness), Harsha (tingling sensation), Shosha (wasting), Dourbalya (weakness), and Angasada. These Upadrava (complication) of Madhumeha, which are nearly similar to the symptoms of diabetic peripheral neuropathy.

It is a common condition, often unreported and inadequately treated resulting in a great deal of morbidity.

The functions of peripheral nerves are damaged in diabetic peripheral neuropathy. In Ayurveda, Vata Dosha especially Vyanavayu performs the functions of peripheral nerves. The functions of normal Vata Dosha are Utsahashakti (enthusiasm), Shwasa Prashwasa Kriya (respiration), Chesta (motor and reflex activities) etc; hence it acts as receptor, as well as a stimulator.

The function of a peripheral nerve is to transmit signals from the spinal cord to the rest of the body or to transmit sensory information from the rest of the body to the spinal cord. Nerve impulse can be correlate with functions of normal Vata Dosha as it is self-originated, propagated, it reaches anywhere. Hence, the disease Diabetic peripheral neuropathy is considered as an abnormal function of Vata Dosha.

Prevalence of diabetic peripheral neuropathy in India is about 26.1%. In region of Maharashtra, it was found to be 30.3% in 2015 study. As estimated, it is 2.8% affecting 171 million people worldwide, in year 2000. With current trends, the prevalence worldwide is estimated to reach 4.4%, affecting 366 million people by the year 2030.

Hypothesis

  • H0 - Madhutailika Basti has no significant effect on Madhumehajanya Nadipratan Shothar.t Diabetic Neuropathy
  • H1 – Madhutailika Basti has significant effect on Madhumehajanya Nadipratan Shothar.t Diabetic Neuropathy

Need of Study

Diabetic neuropathy is relatively earlier and commonest poorly controlled complication occurring in almost every 3rd diabetic in same form or the other. Painful diabetic peripheral neuropathy is treated with tricyclic antidepressants, anticonvulsants, opioids, and topical capsaicin, of which duloxetine and pregabalin have been approved by the US FDA. These regimens are effective but most of them are expensive and having side effect. Madhutailika Basti is believed to have a noteworthy role in the management of such impaired metabolic condition by importing equilibrium state of Doshas, nourishes the Dhatu and maintains the blood sugar level. This research study is being conducted to find out cost effective treatment of Diabetes Neuropathy and improve the quality of life. The number of people suffering from diabetic neuropathy is rising tremendously and at an alarming rate on the global scale which is having a strong negative impact on the entire society at large and hence it is the prime need of the hour to find a reliable solution in order to combat the problem and hence the current study was undertaken.

Aim

To evaluate clinical efficacy of Madhutailika Basti in the management of Madhumehajanya Nadipratan Shotha w.r.t Diabetic Neuropathy

Objectives


  1. To study the pathogenesis of Madhumehajanya Nadipratan Shothar.t. Diabetic Neuropathy
  2. To develop a cost-effective treatment in the management of Madhumehajanya Nadipratan Shothar.t. Diabetic Neuropathy
  3. To improve quality of life & prevent further complications.

Materials and Methods

Materials

Madhutailika Basti (Uttarakhanda in Sharangadhara Samhita, Niruharana Basti (06.29/30/31)



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Ingredients

  • Madhu (Honey) – 4 Pala – (16 Tola) - 160 ml
  • Erandamool Kwatha (Ricinus communis) - 8 Pala (32 tola) = 320 ml
  • Til Tail (Sesamum indicum) - 4 Pala (16 Tola) - 160 ml
  • Satapushpa Kalka (Anethum sowa) - 3 Karsha = 30 gm
  • Saindhava - 1 Karsha = 10 gms

SOP of preparation of Madhutailika Basti

Initially 100ml of Madhu and 5gm of Saindhava Lavana are taken in the equipment. Preparation is continued until Lavana is completely dissolved. Then 100ml of Tila Taila is added and again mixed for specific time period. Here oil layer should become minute globules, mixture should become homogeneous. It is followed by adding of 10gm of Shatapushpa Kalka. Mixing is done so that Kalka particles remain uniformly distributed and do not settle down at the base of the vessel.  At last 320 ml of Erandamula Kwatha is added, mixing is continued until it properly mixes with oil globules. Homogeneity of final mixture is assessed with certain features under the heading Suyojithaniruhalakshana. Finally quantity of 530 ml Basti formulation is measured.

Methods

Research Place: Dept of Kayachikitsa, OPD/IPD, DY Patil School of Ayurveda, Nerul, Navi Mumbai

Table 1: Type of Study Single Arm Clinical Study 

Sample size 30 patients
Medicine Madhutailika Basti
Dose 530 ml
Duration 8 days
Kala Prataha (Abhakata)
Type of Basti Niruhavata
Parihara Kala 16 days

Sample

Total numbers of 30 subjects were selected from the OPD and IPD of Dr. D.Y. Patil College of Ayurveda, Research Institute and Hospital.

The patients were assessed according to case report form.

Method of Data Collection

A Performa was be prepared with details of history, physical examination, pathological investigations.The presenting symptoms were observed 0th day, 10th day, 20th day, 30th day.

Study Design

↓

Screening of the subjects was done

↓

Subjects were selected who were fulfilling the inclusive criteria

↓

Informed consent was taken from each subject

↓

Clinical study was conducted on 30 subjects

↓

CRF was filled

↓

Madhutailika Basti was given for 8 Days

↓

Follow up after every 10 days

↓

Study was conducted for 1 month

↓

Assessment was done according to the data collected

↓

According to the statistical analysis, Observation and result were drawn

↓

Discussion was done after completion of study

↓

Assessment was done according to the data collected

↓

Conclusion was drawn

Inclusion Criteria

  • Age group 18-70 yrs

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  • Patients with clinical positive of type 2 diabetes mellitus having positive symptoms of Diabetic Neuropathy
  • Patients on OHA

Exclusion Criteria

  • Patients having insulin-dependent DM
  • Patients having Diabetic complications other than neuropathy
  • Radiculopathies
  • Coronary artery disease, peripheral artery disease etc
  • Tuberculosis, AIDS, and malignancies.
  • Pregnant women

Duration of Treatment

  • The duration of study was for 1 month.
  • A Performa was prepared with details of history, physical examination, pathological investigations.
  • The presenting symptoms were observed 0th day, 10th day, 20th day, 30th

Investigations

  • CBC, ESR, BSL - Fasting & PP, Lipid Profile, Sr.Creatinine, Urine R/M, ECG
  • Neuropathy analyser (Biothesiometer) which is specifically designed electronic machine to record the perceptions of vibration, heat and cold sensations exactly with the help of computer.
  • We had used this instrument to record these sensations before and after the treatment at Diabecare Diabetes & Thyroid Clinic, Nerul, Navi Mumbai.
  • Vibration perception study - It is used as a measure of large nerve fibre function in Studies of patient with diabetes and in other disorder.

Assessment Criteria

Table 2: Scoring of symptoms

Gradation Scoring of Symptoms
Numbness  
No numbness 00
Numbness only in feet 01
Numbness on whole lower limbs 02
Numbness on other parts of the body also 03
Tingling sensation  
No tingling sensation 00
Tingling sensation only on feet 01
Tingling sensation on whole lower limbs 02
Tingling sensation on other parts of the body together with lower limbs 03
Burning sensation  
No burning sensation 00
Burning sensation only in foot soles 01
Burning sensation in whole lower limbs 02
Burning sensation in all over the body 03
Pain  
No pain 00
Pain Only in feet 01
Pain in legs 02
Pain in legs with difficulty in walking 03

Other Parameters

Table 3: Neuropathy Disability Score

Parameter Grade 0 Grade 1 Grade 2 Total sum for both limbs
Ankle Reflex Normal reflex Present on reinforcement Absent 4
Vibration Present Reduced/Absent - 2
Pin Prick Present Absent - 2
Temperature Present Absent - 2

Maximum abnormal score is 10,

  • Score of 3-5: symptoms of Mild Neuropathy,
  • Score of 6-8: symptoms of Moderate Neuropathy,

Score of 9 or 10: symptoms of Severe Neuropathy

Observations and Results

Table 4: Wilcoxon Test

SN Variables BT AT p value Result Relief %
1. Suptata 95 55 < 0.0001 ES 47.10%
2. Hastpada Chimcimayan 85 60 < 0.0023 ES 29.41%
3. Daha 94 56 < 0.0001 ES 40.42%
4. Pain 88 58 < 0.0001 ES 34.09%
5. NDS 239 137 < 0.0001 ES 42.68%
ES - Extremely Significant

The Madhutailika Basti provided highly significant relief in all the symptoms.

  • p value of Suptata is <0.0001, hence result is extremely significant.
  • p value of Hastpada Chimcimayan is <0.0023, hence result is extremely significant.
  • p value of Daha is <0.0001, hence result is extremely significant.
  • p value of Pain is <0.0001, hence result is extremely significant.

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  • p value of NDS is <0.0001, hence result is extremely significant.

Table 5: Paired ‘t’ Test

SN Variables BT AT T value P value Result % Relief
1. HB 13.19 13.22 1 0.1628 NS -0.22%
2. ESR 13.086 13.733 0.3725 0.3561 NS -4.94%
3. Cholesterol 196.63 192.5 0.914 0.1841 NS 2.10%
4. Bilirubin 0.82 0.8067 3.34 <=0.0012 ES ES
5. BSL Fasting 128.05 118.09 2.565 0.0079 ES ES
6. BSL PP 200.22 176.77 3.189 0.0017 ES ES
7. SR Cretenine 0.8029 0.7968 2.108 0.0217 ES ES
8. SR Uric Acid 6.054 6.107 2.257 0.0159 ES ES
NS - Non-Significant, ES - Extremely Significant
  • P value of HB is 1628 hence result is non-significant.
  • P value of ESR is 3561 hence result is non-significant.
  • P value of Cholesterol is 1841 hence result is non-significant.
  • P value of Bilirubin is <=0.0012 hence result is
  • P value of BSL Fasting is 0079 hence result is extremelysignificant.
  • P value of BSL PP is 0017 hence result is extremelysignificant.
  • P value of SR Cretenine is 0217 hence result is extremelysignificant.
  • P value of SR Uric Acid is 0159 hence result is extremelysignificant.

Vibration Perception Test (VPT)

Table 6: Right Foot

SN Variables BT AT T value P value Result Relief %
1. Toe 16.791 13.894 7.126 <0.0001 ES 17.25%
2. 1st Mth 16.263 13.701 6.871 <0.0001 ES 15.75%
3. 3rd Mth 15.765 12.909 6.072 <0.0001 ES 18.12%
4. 5th Mth 14.425 11.89 5.808 <0.0001 ES 17.57%
5. Instep 14.674 12.351 5.425 <0.0001 ES 15.83%
6. Heel 14.787 12.712 4.543 <0.0001 ES 14.03%
ES - Extremely Significant

Table 7: Left Foot

SN Variables BT AT T value P value Result Relief %
1. Toe 15.447 12.518 6.38 <0.0001 ES 18.96%
2. 1st Mth 15.394 12.91 5.196 <0.0001 ES 16.14%
3. 3rd Mth 14.736 12.477 4.469 0.0001 ES 15.33%
4. 5th Mth 14.008 12.48 3.967 0.0004 ES 10.91%
5. Instep 13.731 11.758 3.741 0.0008 ES 14.37%
6. Heel 14.383 12.094 5.194 <0.0001 ES 15.91%
ES - Extremely Significant

Table 8: Age wise Distribution of 30 patients.

Age in yrs. No. of patients Percentage
40-50 4 13.33 %
51-60 12 40.00%
61-70 10 33.33%
70 & Above 4 13.33%

Age: In this, number of patients i.e., 13.33% belonged to age group of 40-50yrs., followed by 40% patients to 51-60 yrs. age group, 33.33% patients belonged to age group of 61-70 yrs. Followed by 13.33% patients to age group 70 yrs& above.

Table 9: Gender wise distribution of 30 patients

Sex No. of patients Percentage
Male 11 36.67%
Female 19 63.33%

Gender: It is evident from table that maximum no. of patients i.e., 63.33% was female and 36.67% were male.

Table 10: Religion wise Distribution of 30 Patients

Religion No. of patients Percentage
Hindu 26 86.67%
Muslim 4 13.33%

Religion: In this series of 30 patient maximum number of patients i.e. 86.67% patients were Hindu, whereas 13.33% patients were from Muslim community.

Table 11: Occupation wise Distribution of 30 Patients.

Occupation No. of patients Percentage
Service 6 20.00%
Housewife 14 46.67%
Retired 7 23.33%
Business 3 10.00%

Occupation: Maximum number of patients i.e. 20% patients were doing service, followed by 46.67 % were housewives 23.33% patients were Retired, and 10 % were in business.

Table 12: Marital status of 30 Patients.

Marital Status No. of patients
Married 35
Unmarried 0

Marital status: The maximum i.e. 100% of the patients were married, followed by 0% patients were unmarried.


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Table 13: Diet Habit of 30 Patients

Diet No. of patients Percentage
Vegetarian 6 20.00%
Mixed 24 80.00%

Diet Habit: Patients (20%) of this series were vegetarian and 80% were having the habit of mix diet of vegetarian and non-vegetarian.

Table 15: Prakriti wise Distribution of 30 patients

Prakruti No. of patients Percentage
Vata-Pitta 4 13.33%
Kapha-Vata 18 60.00%
Kapha-Pitta 8 26.67%

Prakriti: All the patients of this series were having Dvandaja Prakriti with 26.67 % patients of Kapha-Pitta and 60 % of Vata-Kapha Prakriti. Remaining 13.33% patients were of Vata-Pitta Prakriti.

Table 16: Agni wise Distribution of 30 patients.

Agni No. of Patients Percentage
Sama 0 0.00%
Vishama 7 23.33%
Tikshna 3 10.00%
Manda 20 66.67%

Agni: 66.67 % patients were of Mandagni, 23.33 % were of Vishamaagni, 10 % patients were of Tikshnaagni, and none patients were of Samaagni.

Table 17: Koshtha wise Distribution of 30 patients

Kostha No. of Patients Percentage
Krura 7 23.33%
Mridu 2 6.67%
Madhyam 21 70.00%

Koshta: Maximum number of patients of this series were of Madhyamakoshtha (70 %), followed by Krura (23.33%) and Mridu (6.67%) Koshtha.

Table 18: Socioeconomic wise distribution of 30 patients

Class No. of Patients Percentage
Upper Class 10 33.33%
Middle Class 17 56.67%
Lower Class 3 10.00%

Socioeconomic: Maximum number of patients of this series were from Middle class (56.67 %), followed by Upper Class (33.33%) and Lower Class (10%).

Discussion

Madhutailka Basti maintains the equilibrium of the body tissue with Hridya and prevents exhaustion or Dhatupaka to prevent loss of Ojas, and nourishes all Dhatu  tissue  including Mansa- Majja and Shukra and enhances  more strength  to  the Dhatus  at  the cellular levels and increase the proper cellular.

It produces the following changes:

  • Cure the vitiated or aggravated Dosha (elimination of circulatory waste products)
  • Increases digestive capacity (altered metabolism - Agni Sanrakshan)
  • Purification of Koshtha and remove the constipation (Koshthashudi)
  • Strengthen the host defence mechanism without increasing circulatory levels of sugar, facts and metabolities.
  • Enhances the function of all Agni Sthula and Sukshmaagni (Aamapachana)
  • Production of better Dhatus and Upadhatus (immunomodulatory action - Dhatusanrakshana)
  • Enhances strength of body (adaptogenic activity)
  • Proper functioning of nervous tissues (improvement of micro circulation by modulation of macrophage function - Strotoshodhana)
  • Increases the resistance of body (Dhatuvardhana - maintain tissue regeneration).

From the above discussion it is clear Madhutailika Basti is one among Yapna Basti. It is Nirapada and Nishparihara / Ishatparihara, having both Langhana as well as Brihmana Karma, this is Nishparihara and Nirapada Basti can be practiced even in Bala, Vruddha, Stree, Sukumaras without any complications. It is Pushkala Phala Pradhana and Sarvakaladeyamana Basti like Matra Basti. “Yasmat Madhu Cha Tailam Cha Pradhanyenadeeyate.” This unique Basti contains Madhu and Taila as main ingredient, hence this Basti is named as Madhutailika Basti. Madhu is Yogavahi, and basically it does Karshana by Rukshadiguna. Simillarly Tilataila also causes Lekhana by its Teekshnoshnadiguna after reaching each and every Srotas by its Sukshmaguna. Basti


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alleviates the morbid Vata from the root along with other Dosha and in addition to that, it nourishes the body tissues.

Conclusion

Ayurveda suggested use of Shodhana Chikitsa for the management of metabolic disorder such as Diabetes. Shodhana Chikitsa pacifies vitiated Doshas and break pathogenesis of disease. Basti Karma normalizes Vata, Kapha, Meda, Kleda and Sneha for the management of Avaranjanya Madhumeha. Basti controls Vyan and Apan Vayu which play significant role in the pathogenesis of Madhumeha. Basti reduces Shirahshoola, Anidra, Bhrama and Santapa which may precipitate Diabetes. The proposed autoimmune theory of modern science may be correlated to the Oja Dushtiavastha seen in long lasting Prameha and its Upadravas especially Diabetic Neuropathy. Although there was good symptomatic relief in Diabetic Neuropathy at the end of the trial revealed in these patients.

The patients showed excellent improvement in almost all the symptoms. The more bothering symptoms of Diabetic Neuropathy were pain, burning sensation, tingling sensation, numbness and hyperaesthesia. All these symptoms appeared to have improved in 30 days. The present study is carried out to evaluate the effect of Madhutailika Basti based on the properties like Medho Kaphahara and Vatahara, Deepana, Pachana, and Srotoshodhaka. Madhutailika Basti is believed to have a noteworthy role in the management of such impaired metabolic condition by importing equilibrium state of Doshas, nourishes the Dhatu and maintains the blood sugar level. This research study is being conducted to find out cost effective treatment of Diabetes Neuropathy & improve the quality of life.

Thus, procedure acts only on functional deformity and not on the structural deformity because this disease is Asadhya. No untoward effect of the drug was noticed after administration for a period of 8 days.

Result obtained with respect to the parameter burning sensation, tingling sensation, numbness, weakness & Neuropathy Disability Score had shown statistically improvement. Madhutalika Basti present window of opportunity in the clinical management of Diabetic Neuropathy. There were symptomatic

relief in symptoms of DN in 4 weeks of treatment. There were no adverse effects were noted in present study. This type of clinical study should be conducted on large sample size to get further findings. Healthy dietetics and healthy lifestyle with the use of Ayurvedic drugs with singularly or in combination with modern drugs, depending upon the need, contributed significantly to achieve.

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