| CTRI Number |
CTRI/2025/03/083376 [Registered on: 25/03/2025] Trial Registered Prospectively |
| Last Modified On: |
21/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To find the efficacy of Brihat-Vridhadaruka Sama Churna and Navaka Guggulu in the management of Sthoulya(Obesity) |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Study to evaluate the efficacy of Brihat-Vridhadaruka Sama Churna and Navaka Guggulu in the management of Sthoulya w.s.r. 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 Nisha |
| Designation |
PG Scholar |
| Affiliation |
Institute for Ayurved Studies and Research |
| Address |
Room no 56
PG Department of Kayachikitsa
Institute for Ayurved Studies and Research Hospital
Shri Krishna Ayush University
Kurukshetra
Sector 8
Umri Road
Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
9599762576 |
| Fax |
|
| Email |
ynisha38@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neha Lamba |
| Designation |
Associate Professor |
| Affiliation |
Institute for Ayurved Studies and Research |
| Address |
Institute For Ayurved Studies and Research
Shri Krishna Ayush University
Kurukshetra
Sector 8
Umri Road
Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
9736333868 |
| Fax |
|
| Email |
drlamba.neha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nisha |
| Designation |
PG Scholar |
| Affiliation |
Institute for Ayurved Studies and Research |
| Address |
Room no 56
PG Department of Kayachikitsa
Institute for Ayurved Studies and Research Hospital
Shri Krishna Ayush University
Kurukshetra
Sector 8
Umri Road
Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
9599762576 |
| Fax |
|
| Email |
ynisha38@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute for ayurved studies and research, sector 8, Umri road, kurukshetra, 136118 |
|
|
Primary Sponsor
|
| Name |
Institute for Ayurved studies and research |
| Address |
Institute for Ayurved studies and research, sector 8, Umri road, kurukshetra, 136118 |
| Type of Sponsor |
Government medical college |
|
|
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 NISHA |
Institute for Ayurved studies and research |
Room no 56, department of kayachikitsa, Institute for Ayurved studies and research, sector 8, Umri road, Kurukshetra, 136118
Kurukshetra
HARYANA |
9599762576
ynisha38@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shri krishna Ayush University, kurukshetra |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E660||Obesity due to excess calories. Ayurveda Condition: MEDOVAHASROTODUSHTIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Navaka Guggulu, Reference: Bhaisajya Ratnavali Chapter 39 Verse 43, Route: Oral, Dosage Form: Guggulu , Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Brihat Vridhadaruk Sam Churna , Reference: Gadanigraha Part 3 Shalyatantra khand chapter 2 slipadarogadhikara verse 21-23, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -kanji), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 The patient has signs and symptoms of Sthoulya explained in Ayurvedic texts.
2 Patients with the age group 18 – 60 years of both genders.
3 The patient having 10% excess weight than desirable weight according to height, sex, and age.
4 The patient with a BMI of 25 to 34.9.
5 Waist hip ratio: males more than 102 cm and females more than 88 cm
6 Ready to give written and informed consent. |
|
| ExclusionCriteria |
| Details |
1 The patient is below 18 years and above 60 years of age of both genders.
2 The patient with a BMI of 35 and more than 35.
3 Patients suffering from diabetes mellitus, endocrinal disorders, cardiovascular diseases, hypertension, respiratory diseases, polycystic ovarian syndrome, and other such diseases in which the person cannot do his/her routine daily activities will be excluded.
4 Patients of Acute renal failure, chronic renal failure and Nephrotic syndrome.
5 Patients who have a known history of HIV, Hepatitis and other infectious diseases.
6 Patients with autoimmune disorders.
7 Pregnant and lactating mothers.
8 Alcoholics and other drug abusers.
9 Patient on prolonged medication with Corticosteroids, Antidepressants, Anticholinergic, Anticonvulsant, Antipsychotics, etc. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The proportion of the patient’s showing improvement in the BMI level after the participation in study. |
60 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Change in waist- hip ratio.
2 Change in quality of life. |
75 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
23/06/2025 |
| 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 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
|
Obesity is defined as abnormal or excessive fat accumulation that presents a risk to health. In Ayurveda Obesity is mentioned as Sthoulya Roga. It is classified as a metabolic condition under the category of Medoroga which is caused by a malfunctioning of Medadhatvagni. In the Astoninditiya Adhyaya of Charaka Samhita, Acharya gives the definition of Sthoulya "medomam-saativrudhatwat chalasphik-udarastana Ayatha-upachayanutsaha sthaulya-itiuchyate". The world is looking to Ayurveda for a successful management strategy and obesity prevention. Because allopathic treatment of obesity such as bariatric surgery is expensive and medications have various side effects. Through certain dietary and lifestyle modifications, ayurveda has placed a strong focus on all-encompassing strategies that help people lose extra weight and maintaining it off. To help us control the condition, numerous theories and treatments have been proposed. The present study is conducted to compile the available information regarding Sthoulya, in classical literature of Ayurveda and to validate the statement of Acharyas. So here also an attempt has been made to evaluate the efficacy of Brihat Vridhadaruksama Churna with Anupana of Kanji in Sthoulya which is a Shamana Chikitsa. With limited adoption of the first line of treatment in the form of moderate exercise and dietary measures is oriented to suit the people with reasonable time and money. |