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CTRI Number  CTRI/2024/03/063863 [Registered on: 08/03/2024] Trial Registered Prospectively
Last Modified On: 02/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of Vaman Karma in Vasant Ritu in healthy individuals.  
Scientific Title of Study   A Clinical study to evaluate the effect Of Vaman Karma in Vasant Ritu in healthy individuals  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Dr Vijay Chaudhary  
Designation  Principal cum Dean  
Affiliation  Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital  
Address  Principal cum Dean Room no 105 Admin block (Principal Office) Ground Floor Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola

Kangra
HIMACHAL PRADESH
176115
India 
Phone  9418130228  
Fax    
Email  drvijaychaudhary@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr Vijay Chaudhary  
Designation  Principal cum Dean  
Affiliation  Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital  
Address  Principal cum Dean Room no 105 Admin block (Principal Office)Ground Floor Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola

Kangra
HIMACHAL PRADESH
176115
India 
Phone  9418130228  
Fax    
Email  drvijaychaudhary@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Diksha Sharma 
Designation  Post Graduation Scholar 
Affiliation  Rajiv Gandhi Government Ayurvedic Colleage and Hospital 
Address  Room no 701,Department of Panchkarma,Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola

Kangra
HIMACHAL PRADESH
176115
India 
Phone  9418971241  
Fax    
Email  dikshasharma9070@gmail.com  
 
Source of Monetary or Material Support  
Baijnath Pharmacy, Paprola ,Distt kangra ,Himachal Pradesh  
Charak Pharmacy,Rajiv Gandhi Ayurvedic College & Hospital,Paprola, Distt. Kangra  
Research Institute in ISM jogindernagar, Distt. mandi himachal pradesh  
 
Primary Sponsor  
Name  Prof. Dr. Vijay Chaudhary 
Address  Principal cum Dean Rajiv Gandhi Government Post Graduate Ayuevedic College & Hospital, Paprola , Distt. kangra 
Type of Sponsor  Other [Self] 
 
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 
Prof Dr Vijay Chaudhary  Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola  Room number 703, Department of Panchkarma,Rajiv Gandhi Government Post Graduate College and Hospital , Paprola
Kangra
HIMACHAL PRADESH 		 9418130228

drvijaychaudhary@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy individuals 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-vamana-karma/ pracCardanam, वमन-कर्म/ प्रच्छर्दनम् (Procedure Reference: Charak kalap sthan, Procedure details: In Preoperative Aampachan & Snehpaan is done 3 to 5 days before procedure according to Koshtha & Prakruti of individual. Kapha Utkleshit Aahar is given to individual a day prior to main procedure. Sarvang Abhyang Swedana is done a day before & on the day of main procedure. On the day of main procedure early morning sarvang abhyanga swedana is done ,aakanth yavagupaan & then madanphalpippali churan with saindhav ,madhu & Madhuyashti Kashaya Is given to individual. Vaman vega shudhi is measur)
(1) Medicine Name: madhuyashti, Reference: Charak kalap sthan, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 150(ml), Frequency: od, Duration: 1 Days
(2) Medicine Name: Madan phal pippali, Reference: Charak kalap sthan, Route: Oral, Dosage Form: Churna/ Powder, Dose: 4(g), Frequency: od, Duration: 1 Days
2Comparator ArmLifestyle--Dinacarya: NA, Ritucarya: Follow vasant ritu charya, Acara Rasayana:NA, Other:NA, Pathya/Apathya:yes, Pathya:Aahar Pathya: Eat katu tikta and kashya ras,Eat laghu and ruksha and purana yava and wheat, Eat munga ,kultha and carrot ,turnip,methi,pumpkin karella. Drink honey mixed water. Viharaj Pathya: Do vyayam, vaman,dhumpaan, tikshan nasya, kaval, udvartan ubatan., Apathya:Aaharaj Apathya: Avoid madhur,amla,lavanras and snigdha and guru aahar Viharaj Apathya:Avoid Divaswapan
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Healthy individuals fit for vaman as per classical text.
2. Healthy individuals between 18 years and 60 years 
 
ExclusionCriteria 
Details  1.Healthy individuals unfit for vaman as per classical text.
2. Pregnant women and lactating women.
3. Mensturating women
4. individuals suffering from diabetes,hypertension,renal disorder,cardiac disease, chronic peptic disorder and traumatic condition.
5. Healthy individuals below 18 years and above60 years
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
improvement in digestion, physical and mental well being. attainment of good health profile  2 Months 
 
Secondary Outcome  
Outcome  TimePoints 
improvement in quality of life  2 months 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   15/03/2024 
Date of Study Completion (India) 17/05/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   The Rajiv Gandhi Government Postgraduate Ayurvedic College and Hospital Paprola is one of the premier Ayurveda Research Institute in North India where innovative Ayurveda Research work is carried out throughout year. I am a PG Scholar at Department of Panchkarma in this institute and I am undertaking this Research Trial as topic for PG thesis. I would like to publish my research trial after completion of trial as soon as possible. Healthy individual will be selected from campus/faculty/ OPD of Rajiv Gandhi Government post graduate Ayurvedic college and Hospital paprola. Two groups of 50 patients each will be Chosen on the basis of inclusion and exclusion criteria. Group 1 will be given Vaman in vasant ritu to know the effect of Vaman Karma in Vasant Ritu in healthy individuals and Group 2 will be observed in Vasant ritu for general health. The importance of Vaman karma in Healthy individuals in Vasant Ritu to improve their quality of life and General Health Profile. This will also improve their Physical and Mental wellbeing.  
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