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CTRI Number  CTRI/2024/06/068875 [Registered on: 13/06/2024] Trial Registered Prospectively
Last Modified On: 12/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to compare the efficacy of Gomutra Haritaki Nitya Virechana along with Udvartana and Triphala Kashaya Nitya Virechana along with Udvartana in the management of Sthaulya Or Obesity. 
Scientific Title of Study   Randomized open labelled controlled clinical study to evaluate the efficacy of Gomutra Haritaki Nitya Virechana along with Udvartana in Sthulya with referance to Obesity. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sridhar Babu K V 
Designation  PG Scholar 
Affiliation  Sri Sri College Of Ayurvedic Science And Research, Banglore 
Address  Room No-8, Department of Panchakarma- OPD, Sri Sri College Of Ayurvedic Science And Research Hospital, 21st K.M Kanakapura Road Udayapura, Banglore

Bangalore
KARNATAKA
560082
India 
Phone  9902684061  
Fax    
Email  babukv54@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Prajwal Narayan 
Designation  Professor 
Affiliation  Sri Sri College Of Ayurvedic Science And Research, Banglore 
Address  Room No-8, Department of Panchakarma- OPD, Sri Sri College Of Ayurvedic Science And Research Hospital, 21st K.M Kanakapura Road Udayapura, Banglore

Bangalore
KARNATAKA
560082
India 
Phone  8951072206  
Fax    
Email  prajwal.ayurveda@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Prajwal Narayan 
Designation  Professor 
Affiliation  Sri Sri College Of Ayurvedic Science And Research, Banglore 
Address  Room No-8, Department of Panchakarma- OPD, Sri Sri College Of Ayurvedic Science And Research Hospital, 21st K.M Kanakapura Road Udayapura, Banglore

Bangalore
KARNATAKA
560082
India 
Phone  8951072206  
Fax    
Email  prajwal.ayurveda@gmail.com  
 
Source of Monetary or Material Support  
Sri Sri College Of Ayurvedic Science And Research Hospital,21st K.M Kanapura Road, Udayapura, Banglore, Karnataka, India -560082 
 
Primary Sponsor  
Name  Dr Sridhar Babu K V 
Address  Sri Sri College Of Ayurvedic Science And Research,21st K.M Kanakapura Road, Udayapura, Banglore, Karnataka, India-560082  
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 
Dr Sridhar Babu K V  Sri Sri College Of Ayurvedic Science And Research Hospital  Room No-8, Department of Panchakarma- OPD
Bangalore
KARNATAKA 
9902684061

babukv54@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRI SRI INSTITUTIONAL ETHICAL COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E669||Obesity, unspecified. Ayurveda Condition: MEDOROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-virecana-karma िवरेचन-कम. (Procedure Reference: Charaka Samhita Chikitsastana 13/61, Procedure details: Purvakarma-Udvartana will be performed early morning Pradhanakarma- Gomutra Haritaki will be give in the morning withempty stomach Paschatkarma- after complete stoppage of vegas & on hunger Ganji with will given )
(1) Medicine Name: Gomutra Haritaki, Reference: Ashtanga Hridaya Chikitsastana 8/55-56, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 10(g), Frequency: od, Duration: 7 Days
2Comparator ArmProcedure-virecana-karma िवरेचन-कम. (Procedure Reference: Charaka Samhita Chikitsasthana 13/61a, Procedure details: Purvakarma-Udvartana will be performed early morning Pradhanakarma- Triphala Kashaya will be give in the morning with empty stomach Paschatkarma- after complete stoppage of vegas & on hunger Ganji with will given )
(1) Medicine Name: Triphala, Reference: Ashtanga Hridaya Sutrasthana 6/160, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 300(ml), Frequency: od, Duration: 7 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Subjects between the age group of 18 - 60 years irrespective of gender, religion, occupation and socio-economic status.
2.Subjects fit for Udvartana and Nitya Virechana.
3.Subjects with BMI 25-34.9 kg/m2.
4.Subjects who are willing to give a written consent for the treatment.
 
 
ExclusionCriteria 
Details  1.Subjects below 18 years and above 60 years of age.
2.Subjects unfit for Udvartana and Nitya Virechana.
3.Pregnant and lactating women.
4.Patients suffering from diabetes, hypertension, thyroid dysfunction, skin disease and other systemic disorders which intervene with treatment protocol.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
BMI,
Anthropometry- mid arm and mid thigh, waist to hip circumference ratio
skin flod thickness-biceps, mid triceps, subscapular, abdomen,supra iliac, thigh 
0th day, 7th day, 14th day 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 3 
Date of First Enrollment (India)   30/07/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

         Sthaulya is one among the Santarpana Janya Vyadhi which is mentioned under Bahudosha Avastha. Sthaulya if not treated, can lead to Atisthula Lakshana, one of the Ashtanindita Purusha.Therefore, treatment for Sthaulya becomes utmost necessary, to attain Swaasthya.

    Sthaulya can be correlated to over-weight or obesity as per modern science. According to WHO, 1.9 billion adults above age of 18 years were over-weight, out of which 650 million were obese. The prevalence of obesity has been increased multi fold within the last 20 years and continue to rise. In India, more than 135 million individuals are affected with obesity with more prevalence of abdominal obesity. Mortality rate due to obesity and its related complications are increasing day by day. WHO and various governmental organizations are enormously trying to address this issue worldwide as it has caused burden for both the government and the individuals.

        In the classics, management of Sthaulya includes the principle of Guru Cha Atarpana and Karshana to cause Medhaghnta by bringing about Kapha Vilayana. This can be achieved by both Bahya and Abyantara measures. Udvartana (Bahya Chikitsa) having the qualities of Kaphaharana and Medo Vilayana which is able to make the body compact by causing inch loss to individuals.

 

·       Virechana is one among the Panchakarma, which can tackle this Bahudosha Avasta.  Nitya Virechana is one variety of Virechana , which can also be employed for the management of Sthaulya, as it does Sroto ShodhanaGomutra Haritaki is one of the formulations given by Acharya Vagbatta for Sthaulya, as Gomutra Haritaki has Ushna, Ruksha and Virechaniya property. Though various measures or practical methods, even surgery are in vogue to manage Sthaulya, there is still a lot of scope in managing obesity as there is no satisfactory protocol. Hence in this study an approach of Nitya Virechana with Gomutra Haritaki along with Udvartana shall be made.

 
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