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CTRI Number  CTRI/2019/06/019883 [Registered on: 26/06/2019] Trial Registered Prospectively
Last Modified On: 21/06/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Ayurvedic management of Sthaulya with Triphaladighanavati and Vaman and Virechan Panchakarma. 
Scientific Title of Study   “Randomised Controlled Trial on Principles of Management of Sthaulya by Triphaladighanavati after Vamana Specifically on Body Mass Index” 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sagar Anil Gopal 
Designation  PG Kayachikitsa Scholar 
Affiliation  Government Ayurved College and Hospital Nagpur  
Address  Kayachikitsa Department, 2nd floor, Government Ayurveda college, Raghuji Nagar Sakkardara square, Nagpur. 440024

Nagpur
MAHARASHTRA
440024
India 
Phone  8888980476  
Fax    
Email  sagargopal007@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Prakash Kabra 
Designation  Professor Kayachikitsa department 
Affiliation  Government Ayurved College and hospital Nagpur 
Address  Kayachikitsa Department, 2nd floor, Government Ayurveda college, Raghuji Nagar Sakkardara square, Nagpur. 440024

Nagpur
MAHARASHTRA
440024
India 
Phone  9225226567  
Fax    
Email  kabraprakash2711@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Prakash Kabra 
Designation  Professor Kayachikitsa department 
Affiliation  Government Ayurved College and hospital Nagpur 
Address  Kayachikitsa Department, 2nd floor, Government Ayurveda college, Raghuji Nagar Sakkardara square, Nagpur. 440024

Nagpur
MAHARASHTRA
440024
India 
Phone  9225226567  
Fax    
Email  kabraprakash2711@gmail.com  
 
Source of Monetary or Material Support  
OPD, IPD and Casualty of kayachikitsa department Government ayurved hospital, sakkardhara Nagpur 
 
Primary Sponsor  
Name  Self Dr Sagar Gopal 
Address  Kayachikitsa Department, 2nd floor, Government Ayurveda college, Raghuji Nagar Sakkardara square, Nagpur. 440024 
Type of Sponsor  Other [Government Ayurveda College, Nagpur] 
 
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 Sagar Anil Gopal  Government Ayurved Hospital Nagpur   OPD No. 1 Kayachikitsa Department, Ayurveda college and Hopsital, Raghuji Nagar Sakkardara square, Nagpur. 440024
Nagpur
MAHARASHTRA 		 8888980476

sagargopal007@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics comitee Government Ayurved College and Hospital Nagpur   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E669||Obesity, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Vaman followed by Triphaladighanavati  Rukshana Pachan Kvath 20 ml BD will be given to the Sthaulya patients for 5 Days then Snehapana by Triphaladi Tailpana as 30ml,45ml,60ml,75 ml,90ml etc till Samyaka-Sneha. After that local application of Sneha and Sveda for one day then Vamana by Madanphala Pippali Yastimadhu Phanta and Samsarjanakrama according to Shuddhi. after Samsarjanakrama Triphaladighanavati 500mg 2 BD with Ushnodak at Apanakala will be given for 30 days  
Comparator Agent  Virechana followed by Triphaladighanavati  Rukshana Pachan Kvath 20ml BD will be given to the Sthaulya patients for 5 Days then Snehapana by Triphaladi Tailpana as 30ml, 45ml, 60ml, 75ml, 90ml etc till Samyaka-Sneha. After that local application of Sneha and Sveda for three days then Virechana by Ichhabhedi Rasa 250 mg 1 stat early morning with cold water and Samsarjanakrama according to Shuddhi. after Samsarjanakrama Triphaladighanavati 500mg 2BD will be given for 30 days.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1) Patients having clinical features of Sthaulya with respect to Ayurveda classics.
2)Patients of Sthaulya having BMI more than 25Kg/m2and less than 35Kg/m2. (Obese-1 & Obese- 2).
3)Patients of either sex aged between 18- 70 years irrespective of caste, religion, socio economic & educational status.
4)Those patients of Sthaulya who are willing to participate in trial and ready to give written consent will be included.
 
 
ExclusionCriteria 
Details  1)Patients of obesity due to hypothyroidism, Cushing’s syndrome and obesity with any other systemic disorders like Ischemic heart disease will be excluded.
2)Patients of Sthaulya with hypertension and diabetes mellitus will be excluded.
3)Patients of drug induced obesity for example Hormonal replacement therapy, consumption of anabolic steroids etc. will be excluded.
4)Pregnant females & lactating mothers will not be considered.
5)Patients who are currently participating in other clinical trials (since last six months) will be excluded.
6)Those patients who are contra indicated for Vamana and Virechana.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Triphaladighanavati after Vamana have equal effect as that of Triphaladighanavati after Virechana in Sthaulya in reducing weight and Body Mass Index.   52 Days  
 
Secondary Outcome  
Outcome  TimePoints 
1) To evaluate the effect of Vamana followed by Triphaladighanavati on insulin resistance (HOMA-IR) [16] and to compare its result with that of Virechana followed by Triphaladighanavati.  52 Days 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   01/10/2019 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not yet. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Introduction

 Obesity is a major lifestyle disorders, it is a disease which grows rapidly ranking one of the most common chronic metabolic disorder.

Obesity in Ayurveda described under the heading of Sthaulya. Charak has described Sthaulya as a disease of accumulation of excessive Meda and Mamsa Dhatu, which result into pendulous appearance of buttocks, belly and breast.  Atisthula has been classified under Ashta Ninditiya Purush. Sushruta opined that some of Upadrava of Sthaulya are Prameh Pidaka, Jwar, Bhagandar, Vidradhi and Vatvikara.  Charak described eight Dosha of Sthaulya like Javoparodha, Daurbalya, Daurgandhya etc. Charak also explain the Samprapti of Sthaulya.

Vagbhat advocated Shodhana Chikitsa in Sthaulya.  There is involvement of dominant Kapha Dosha and Meda Dhatu so it is thought in mind to evaluate the effect of Vamana followed by Shamana and to compare its results with that of Virechana followed by Shamana in the management of Sthaulya with special reference to Obesity. Effect of Virechana followed by Triphaladighanavati was evaluated by Gaonkar A. (2018) submitted to M.U.H.S. Nashik. She was of the opinion that Virechana followed by Triphaladighanavati significantly reduced weight and total cholesterol. She further added that even administration of Snehapana also reduced weight significantly. Therefore, it was thought in mind that to compare the result of Vamana followed by Triphaladighanavati with that of Virechana

Materials and Methods:

1)     Medium of Dissertation: Language will be in English and Sanskrit words will be used wherever necessary.

2)     Study Type: Randomised Controlled Trial.

3)     Study Centre: OPD and IPD of Kayachikitsa Department of the Institute.

4)     Duration of Study: 18 months.

5)     Duration of Treatment: Trial Group-20 Days Vamana+30Days [Shamana].

                             Control Group -22 Days for Virechana+30 days [Shamana].

6)     Ethical Clearance: From ethics committee of the Institute.

7)     Medium of Dissertation: Language will be in English and Sanskrit words will be used wherever necessary.

8)     Study Type: Randomised Controlled Trial.

9)     Study Centre: OPD and IPD of Kayachikitsa Department of the Institute.

10)  Duration of Study: 18 months.

11)  Duration of Treatment: Trial Group-20 Days Vamana+30Days [Shamana].

                             Control Group -22 Days for Virechana+30 days [Shamana].

12)  Ethical Clearance: From ethics committee of the Institute.

Criteria of Diagnosis:

1.     Clinical examination of all patients will be carried out as mentioned in Classics [7] along with investigations which ever necessary for diagnosis.

2.     Sign and symptoms of obesity will also be considered.

The BMI must be in range of more than 25kg/m2 and less than 35kg/m2(obese-1 and obese-2

Trial Group

Rukshana Pachan Kvath 20 ml BD will be given to the Sthaulya patients for 5 Days then Snehapana by Triphaladi Tailpana as 30ml, 45ml, 60ml, 75 ml, 90ml etc till Samyaka-Sneha. After that local application of Sneha and Sveda for one day then Vamana by Madanphala Pippali Yastimadhu Phanta and Samsarjanakrama according to Shuddhi. after Samsarjanakrama Triphaladighanavati 500mg 2 BD with Ushnodak at Apanakala will be given for 30 days

Control Group

Rukshana Pachan Kvath 20ml BD will be given to the Sthaulya patients for 5 Days then Snehapana by Triphaladi Tailpana as 30ml, 45ml, 60ml, 75ml, 90ml etc till Samyaka-Sneha. After that local application of Sneha and Sveda for three days then Virechana by Ichhabhedi Rasa 250 mg 1 stat early morning with cold water and Samsarjanakrama according to Shuddhi. after Samsarjanakrama Triphaladighanavati 500mg 2BD will be given for 30 days. 

Assessment of patients and Differentiation:

Vamana Group:

Assessment of patients will be done on the basis of clinical feature as per Ayurvedic text, body mass index, waist hip ratio, lipid profile, Serum Insulin (fasting), before starting treatment that is on zero days.  These criteria will be assessed, which will be termed as Before Treatment (B.T. Score).  After Vamana treatment, that means on next day after completion of Samsarjankrama2ndAssesment will be done i.e. Before Shamana assessment will be taken, then follow-up will be taken after one-month course of Triphaladighanavati and this will be termed as After Treatment score (A.T. score).

The patient will be examined every day during Snehapana and Vamana. After completion of treatment the efficacy treatment will be assessed by following subjective as well as objective criteria.

Virechana Group:

Assessment of patients will be done on the basis of clinical feature as per Ayurvedic text, body mass index, waist hip ratio, lipid profile, Serum Insulin (fasting). Before starting treatment that is on zero day these criteria will be assessed, which will be termed Before Treatment (B.T. Score), after Virechana treatment that means on next day after Samsarjan Krama 2ndAssesment will be done. It will be Before Shamana assessment. Then follow-up will be taken after one-month course of Triphaladighanavati and this will be termed as After Treatment score (A.T. score).

Discussion and conclusion:

All the Data will be recorded on C.R.F. These will be classified and will be tabulated in the form of Master Chart. All these will be summarized and analyzed. The matter of Data will be decided and they will be tested by statistical test. That test may be either paired t test or Wilcoxon Signed Rank Test. Further comparison between two groups will be done with the help of either unpaired t test or Man Whitney test. Overall effect of therapy between the two groups will be compared by Chi Square test. Results obtained in two groups will be discussed with the therapeutics. The cause will be described that why such results are obtained with the reasoning where ever possible. Conclusion will be drawn with the help of results of this study.

 

 

 
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