| 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
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E669||Obesity, unspecified. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | 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 | | 2 | Comparator Arm | Procedure | - | 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 |
|
|
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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 Shodhana. Gomutra 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. |