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CTRI Number  CTRI/2020/07/026717 [Registered on: 21/07/2020] Trial Registered Prospectively
Last Modified On: 21/10/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [Panchkarma]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Management of Hypothyroidism through Vaman and Basti therapy 
Scientific Title of Study   An Open Randomized Comparative Clinical Study to Evaluate the Efficacy of Vaman Karma and Madhutailika Basti followed by Vidangadi Leha in the management of Dhatwagnimandya w.s.r. to Hypothyroidism 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Gopesh Mangal 
Designation  Associate Professor  
Affiliation  NIA Jaipur 
Address  Dept of Panchkarma NIA Jaipur Jorawar Singh Gate Amer road

Jaipur
RAJASTHAN
302002
India 
Phone    
Fax    
Email  gmangal108@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Minu Yadav 
Designation  MD Scholar 
Affiliation  NIA Jaipur 
Address  Dept of Panchkarma NIA Jaipur Jorawar Singh Gate Amer road

Jaipur
RAJASTHAN
302002
India 
Phone  9986962382  
Fax    
Email  minuyadav12@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Minu Yadav 
Designation  MD Scholar 
Affiliation  NIA Jaipur 
Address  Dept of Panchkarma NIA Jaipur Jorawar Singh Gate Amer road

Jaipur
RAJASTHAN
302002
India 
Phone  9986962382  
Fax    
Email  minuyadav12@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda 
 
Primary Sponsor  
Name  National Institute of Ayurveda 
Address  Madhav Vilas Palace Jorahawar Singh gate Amer road Jaipur 302002 Rajasthan 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Minu Yadav  National Institute of Ayurveda  OPd room no 2 and IPD of Panchakarma Department , National Institute of Ayurveda, Jaipur 302002, Rajasthan
Jaipur
RAJASTHAN 
9986962382

minuyadav12@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, National Institute of Ayurveda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E039||Hypothyroidism, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Comparator Agent  In this group Vaman Karma will be carried out followed by oral administration of Vidangadi Leha in a dose of 5gm B.D. for 1month in 20 patients.  
Intervention  Intervention  In this group Madhutailika Basti Karma will be carried out followed by oral administration of Vidangadi Leha in a dose of 5gm B.D. for 1month in 20 patients. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patient TSH level above 5.5 μIU/mL
Total T4 level less than normal value
Total Sr. T3 level less than normal value
Patients having clinical features of hypothyroidism
Patients yogya for Vaman Karma and Basti Karma 
 
ExclusionCriteria 
Details  Ischemic heart diseases ï‚·
Uncontrolled hypertension ï‚·
Myocardial Infarction ï‚·
Cerebrovascular diseases ï‚·
Cardiac arrhythmias ï‚·
Pregnancy ï‚·
Active malignant disease ï‚·
Patients Ayogya for Vaman Karma and Basti Karma 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in Thyroid Profile  75 days 
 
Secondary Outcome  
Outcome  TimePoints 
Change in Zulewskis Clinical Score and associated signs and symptoms of Hypothyroidism.   75 days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   03/08/2020 
Date of Study Completion (India) 24/06/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Not yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  through research article publication

  6. For how long will this data be available start date provided 01-12-2022 and end date provided 01-12-2030?
    Response (Others) -  after publication of research article, with no end date

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  

Introduction:

Hypothyroidism is pathological condition of thyroid gland producing deficiency of thyroid hormones. It is usually primary disease of thyroid but may be secondary due to disturbances of hypothalamic-pituitary axis. The hormones regulate essential functions such as heart rate, digestion, physical growth and mental development. An insufficient supply of this hormone can slow life-sustaining processes, damage organs and tissues in every part of the body and lead to lifethreatening complications. According to the concept of Ayurvedic pathophysiology, the fundamental cause behind it is diminution of Agni. Agni converts Ahara dravya into Ahara rasa and then with the help of Bhutagni and Dhatwagni, Poshakansh is made available to the body. Hence any Vikriti i.e. hypo or hyperfunctioning of the Agni is the prime cause of pathogenesis of any disease. There is no direct reference of Hypothyroidism in Ayurveda, but the symptoms can be correlated to symptoms of KaphaAvruta Vata, in particular Kaphaja Grahni and Mandagni Janya Vikara and Bahudoshavastha in general. Acharya Vagbhata has related Jatharagni to Dhatwagni. An increase in Panchakagni makes an increase of Dhatu, other Agni and vice versa. So it can be said that it is basically caused due to dysfunctioning of the Agni. Hypofunctioning of Jatharagni, which in turn, affects Dhatwagni, eventually, brings out pathological sequence & ultimately, the diseased condition is developed. So in a wider term we can infer Hypothyroidism as Dhatwagnimandya. Looking into the Samprapti of the disease, Kaphanashaka chikitsa, Srotoshodhana, Agnideepana and Vatanulomana are the main treatment principles to be considered. Among Panchakarma, Vaman Karma is the best therapy for the elimination of Kapha Dosha and related morbid factors. In Hypothyroidism dominance of Kapha and  Dushti of Rasa Dhatu are the main features. Thyroid Gland is situated in neck region which is the Sthan of Kapha Dosha Kapha predominant symptoms are present in patients of Hypothyroidism. So Vaman Karma is selected as main treatment in one Group for Dhatwagnimandya. Certain symptoms of hypothyroidism are similar to KaphaAvruta Vayu lakshana, So in another group Basti karma was selected as it works on KaphaAvruta Vayu condition. In both the groups, Vidangadi Leha  was given after Vaman Karma and Basti Karma to augment the Agni, which regulates all metabolic activities.   

Materials and Methods:

In the present clinical study entitled “An Open Randomized Comparative Clinical Study to evaluate the efficacy of Vaman Karma and Madhutailika Basti followed by Vidangadi Leha in the management of Dhatwagnimandya w.s.r. to Hypothyroidism”, 40 patients were registered. After complete examination and investigations, were divided into two groups. Only 36 patients completed their treatment in the present study, other 4 patients were registered, but treatment could not be started in any of them due to COVID-19 pandemic. None of the patients in any group discontinued the treatment. 

WASH OUT PERIOD: 15 DAYS

Patients were randomly divided into two groups as mentioned below-

Group A- In this group, 17 patients were treated with Vaman Karma followed by oral administration of Vidangadi Leha in a dose of 5gm B.D. after food for 1month.

Group B- In this group, 19 patients were administered with Madhutailika Basti followed by oral administration of Vidangadi Leha in a dose of 5gm B.D. after food for 1month. 

Vaman procedure - First of all Deepana, Pachana with Panchakol Choorna (5 gm) twice a day after food till appearance of Nirama Lakshana was given. Snehapana with Murcchit Go-Ghrita for 3-7 days as per Kostha was done till the appearance of Samyak Snigdha Lakshana. Sarvanga Abhyanga by Dashamoola Taila and Sarvanga Swedana by the Dashamoola Kwatha was done for 2 days. Vaman was induced by administrating Madanaphala Vamaka Yoga. After Vamana Karma, Dhoompana was done followed by Samsarjana Karma as per the type of Shuddhi. 

Madhutailika Basti:

The preparation of patient and procedure was done as per SOP of Panchakarma department of National Institute of Ayurveda, Jaipur. The Basti was given for 16-days on empty stomach in the morning hours.

Basti Dravya partsMakshika (Honey)- 4 parts, Saindhava (Rock Salt)- 1 part, Tila Taila – 4 parts, Shatapushpa Kalka- 2 parts and Erandamool Kwatha- 8 parts. 

Shamana Aushadha-

Both the groups were given with Vidangadi Leha in the dose of 5gm twice a day after food with lukewarm water. The Leha was given after completion of Samsarjana Krama in Group A and after completion of Madhutailika Basti in Group B. The Leha was given for a duration of 30 days. 

RESULTS-

In Group A there was mean increase in T3 by 2.28%, in T4 by 0.534% and decrease in TSH 4.582% by after complete treatment (Vaman Karma + Vidangadi Leha). Weight and BMI decreased by 5.36% respectively 0.750% after complete treatment. The Total Cholesterol decreased by 12.55%, Serum triglycerides by 26.41%, HDL increased by 12.94%, VLDL decreased by 27.92%, LDL decreased by 21.85%.  In Subjective parameters, Zulewski’s clinical score decreased by 14.03%, oedema decreased by 82.63%,  puffiness reduced by 78.92%, improvement in dry and coarse skin by 28.56%, reduction in breathlessness by 46.66%, relief in constipation by 80.97%, reduction in lethargy by 87.97%, muscle cramps reduced by 84.18%, sleepiness decreased by 61.54%, changes in duration of menstrual blood were non-significant, improvement between two menstrual cycles were non-significant and reduction in hair fall by 81.48%. The overall symptoms reduced by 79.30%.  

In Group B there was mean increase in T3 by 1.98%, increase in T4 by 0.11% and decrease in TSH by 0.681% after complete treatment (Madhutailika Basti + Vidangadi Leha). Weight and BMI decreased by 0.79% and 0.561% respectively after complete treatment. The Total Cholesterol decreased by 2.83%, Serum triglycerides by 5.52%, HDL increased by 12.12%, VLDL decreased by 12.79%, LDL decreased by 7.92%.  In subjective parameters, Zulewski’s clinical score decreased by 7.25%, oedema by 35.99%, puffiness reduced by 47.37%, improvement in dry and coarse skin by 82.02%, reduction in breathlessness by 41.17%, relief in constipation by 75.01%, reduction in lethargy by 84.64%, muscle cramps reduced by 86.35%, sleepiness by 85.72%, changes in duration of menstrual blood and improvement between two menstrual cycle were non-significant and reduction in hair fall by 50.01%. The overall symptoms reduced by 35.47%.  

Intergroup comparison shows that though there was relief in all the Groups, but percentage wise, Group A is better than Group B in increasing T3, T4 and decreasing TSH. In decreasing body weight and BMI Group A is more effective than Group B. In reducing Total cholesterol, Serum triglycerides, Group A was better than Group B.

In Subjective parameters, Group A was better in reducing Zulewski’s clinical score, oedema, puffiness of face, breathlessness, constipation, lethargy, hair fall, sleepiness and general symptomatology and regulating the interval between the cycles than Group B. In reducing dry and coarse skin and muscle cramps parameters Group B was better than Group A. 

CONCLUSION-

Vaman Karma followed by Vidangadi Leha is more effective than Madhutailika Basti followed by Vidangadi Leha in the management of Dhatwagnimandya (hypothyroidism). 



 
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