FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2018/02/012144 [Registered on: 26/02/2018] Trial Registered Retrospectively
Last Modified On: 07/08/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Other 
Public Title of Study   Ayurvedic management of Obesity (Medoroga) by expulsion and pacification of Impurities of body 
Scientific Title of Study   To Evaluate the efficacy of Shodhan and Shaman Chikitsa in Medoroga (Obesity) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Dr Arun Gupta 
Designation  Professor 
Affiliation  Ch. Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, Najafgarh, New Delhi. 
Address  Ch. Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, Najafgarh, New Delhi

New Delhi
DELHI
110073
India 
Phone  9999155377  
Fax    
Email  arun24@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr Arun Gupta 
Designation  Professor 
Affiliation  Ch. Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, Najafgarh, New Delhi. 
Address  Ch. Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, Najafgarh, New Delhi

New Delhi
DELHI
110073
India 
Phone  9999155377  
Fax    
Email  arun24@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Aditya Dev 
Designation  PG Scholar 
Affiliation  Ch. Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, Najafgarh, New Delhi 
Address  PG Dept Of Panchkarma, Ch. Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, Najafgarh, New Delhi.
Room No. A-16, Housing Block -A, Ch.Brahm Prakash Ayurved Charak Sansthan, Khera Dabar
New Delhi
DELHI
110073
India 
Phone  7011250535  
Fax    
Email  adityaabhishekdev@gmail.com  
 
Source of Monetary or Material Support  
Ch.Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, Najafgarh, New Delhi-73 
 
Primary Sponsor  
Name  Ch Brahm Prakash Ayurved Charak Sansthan 
Address  Khera Dabar, Najafgarh, New Delhi -73 
Type of Sponsor  Other [State Ayurvedic 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 Arun Gupta  Ch. Brahm Prakash Ayurved Charak Sansthan Hospital  PG Department Of Panchkarma & OPD No. 4 and 5
New Delhi
DELHI 		 9999155377

arun24@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC Ch. Brahm Prakash Ayurved Charak Sansthan Goverment of NCT of Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E669||Obesity, unspecified, Patients Suffering from Obesity,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Chitrakadi vati, Mahatriphala ghrit, abhyadi modaka, Lekhana basti  1. Chitrakadi vati 2 tab BD for 3days 2. snehapana with mahatriphala ghrit in increasing dose as per koshtha& agni for 3-7 days in morning with empty stomach 3. Vamana after samyak snigdha lakshana , 1day vishrama kala will be given. During vishrama kala sarvanga abhyanga with til taila ( 35 min) and sarvanga swedana (10-15 min)will be done in the evenning of vishramakala kaphautklishta ahar vihar will be given. on the the next day after sarvanga abhyanga and sarvanga swedan vaman with madanphala in antarnakhmushti praman in morning with empty stomach will be given. vamanopag dravya - cow milk yashtimadhu phanta and lavanodaka as per requirment 4.sansarjan krama -as per shuddhi ( from the evening of vaman) and duration 3 to 7 days. 5.Snehapan with mahatriphala ghrit for 3 days as per koshtha and agni will be given in increasing dose 6.Virechan - After samyak snigdha lakshan 3 days vishram kala.During vishramkala sarvanga abhyanga with til taila (35 min) and sarvanga swedan ( 10-15 min) will be done then on 4th dayafter sarvanga abhyanga and sarvanga swedana will be given abhayadi modak as per koshtha and agni will be given in pitta kala with empty stomach 7. Sansarjan krama -Diet as per shuddhi ( from the evening of the virechan day ) for 3 to 7 days 8.lekhan basti will be given for 8 days 9.Shamana Chikitsa- varunadighana kwath after shodhana for 30 days 40 ml BD 60 minutes before meals will be given 
Intervention  chitrakdi vati, Mahatriphala ghrit, Madanphala, abhyadimodaka, Lekhana basti  1. Chitrakadi vati 2 tab BD for 3days 2. snehapana with mahatriphala ghrit in increasing dose as per koshtha& agni for 3-7 days in morning with empty stomach 3. Vamana after samyak snigdha lakshana , 1day vishrama kala will be given. During vishrama kala sarvanga abhyanga with til taila ( 35 min) and sarvanga swedana (10-15 min)will be done in the evenning of vishramakala kaphautklishta ahar vihar will be given. on the the next day after sarvanga abhyanga and sarvanga swedan vaman with madanphala in antarnakhmushti praman in morning with empty stomach will be given. vamanopag dravya - cow milk yashtimadhu phanta and lavanodaka as per requirment 4.sansarjan krama -as per shuddhi ( from the evening of vaman) and duration 3 to 7 days. 5.Snehapan with mahatriphala ghrit for 3 days as per koshtha and agni will be given in increasing dose 6.Virechan - After samyak snigdha lakshan 3 days vishram kala.During vishramkala sarvanga abhyanga with til taila (35 min) and sarvanga swedan ( 10-15 min) will be done then on 4th dayafter sarvanga abhyanga and sarvanga swedana will be given abhayadi modak as per koshtha and agni will be given in pitta kala with empty stomach 7. Sansarjan krama -Diet as per shuddhi ( from the evening of the virechan day ) for 3 to 7 days 8.lekhan basti will be given for 8 days  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. The patints having classical signs & symptoms of medoroga
2. The patients having BMI not <25 & >40 kg/centimeter square.
3. The patients with Controlled Diabetes & Controlled hypertension. 
 
ExclusionCriteria 
Details  1. The patients below the age of 20 years and above 60 years
2. Patients having hypothyroidism
3. The patients with evidence of renal, cardiac and hepatic involvement.
4. The patients on steroid treatment. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
40- 60 % remission of sign & symptoms of medoroga(Obesity)  40- 60 % remission of sign & symptoms of medoroga(Obesity) 
 
Secondary Outcome  
Outcome  TimePoints 
Improve quality of life  2 months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   10/02/2018 
Date of Study Completion (India) 31/12/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Medoroga or obesity is a medical condition in which excess body fat has accumulated to the extent that it may have an negative effect on health. People are generally considered obese when their BMI (body mass index ), a measurment  obtained by dividing a persons weight by square of person`s height . In present study 60 patients suffering Medoroga (obesity) will be  selected from OPD of Ch. Brahm Prakash Ayurved Charak Sansthan Hospital, New Delhi. These selected patients will be divided into two groups viz. Group-A & Group-B with 30 patients in each group. In group -A 30 patients will be given shodhana chikitsa (vamana, virechana, basti) and in Group-B 30 patients will be given shodhan chikitsa followed by shaman chikitsa.

Group - A - Shodhana Chikitsa
  1.  Deepana and Pachana-2 chitrakadi vati twice a day after taking meal for 3 days
  2.  Snehapana - with Mahatriphala ghrita. Dose - As per Koshtha and agni. Time and Duration - In morning with empty stomach for 3-7 days.
  3. Abhyanga and Swedana - Abhyanga with tiltaila (35 min) and sarvanga sweda (10-15 min). Duration - 1 day
  4. Vamana karma - Vamanopaga with madanphala (antranakhmushthi pramana) with  madhu.  Vamanopaga dravya - Yashtimadhu phanta and lavanodaka as per requirement.  Time of administration and duration : In Morning kapha and  for 1 day
  5. Sansrajana krama - Diet as per shuddhi . Time of administration and duration - From the evening of vamana day for 3-7 days
  6. Snehapana - with Mahatriphala ghrita. Dose - As per koshtha and agni. Time and Duration - In  morning with empty stomach for 3days
  7. Abhyanga and Swedana - Abhyanga with tiltaila (35 min) and sarvanga sweda(10-15 min). Duration - 3 day
  8. Virechana Karma - with Phaltrikadi kwath & abhyadi modak. Dose - As per koshtha & agni.  Time of administration - From the evening of virechana day for 3-7 days.
  9. Sansrajana krama - Diet as per shuddhi.  Time of administration and duration - from the evening of virechana day for 3-7 days.
  10. Lekhana Basti  in dose 550ml for 8 days. 


Group - B - Shodhana chikitsa followed by shamana snehapana
 In this group after shodhan chikitsa (as described above) shamana chikitsa with Varunadighana kwatha in 60ml dose 60minutes before meals.

Assessment criteria
The improvement provided  will be  assessed  on the basis of relief in sign and symptoms of the disease  and by BMI index.

Sample size - 60

Duration of Study - 2 months for each patient including follow up.

Follow up of patient - Initial assessment - 0day
                                  Follow up after vaman, after virechana, after basti, 60days. 
 
Close