| CTRI Number |
CTRI/2025/07/090039 [Registered on: 02/07/2025] Trial Registered Prospectively |
| Last Modified On: |
02/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
to see the effectiveness of medicines bilwadi kwath and amritadi guggul in sthaulya( obesity ). |
|
Scientific Title of Study
|
A comparative study to evaluate the efficacy of Amritadi guggul and Bilwadi kwath in the management of Sthaulya wsr 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 |
sangeeta dev |
| Designation |
PhD Scholar |
| Affiliation |
Govt. Ayurvedic college and hospital, Patiala |
| Address |
Government ayurvedic college and hospital patiala
Patiala
PUNJAB
147003
India |
| Phone |
8630212064 |
| Fax |
|
| Email |
s09608951@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Rakesh Sharma |
| Designation |
professor |
| Affiliation |
Govt. Ayurvedic college & hospital, Patiala |
| Address |
govt. ayurvedic medical college, patiala
Patiala
PUNJAB
147001
India |
| Phone |
9814779242 |
| Fax |
|
| Email |
vaidyaras03@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
sangeeta dev |
| Designation |
PhD Scholar |
| Affiliation |
Govt. Ayurvedic college, Patiala |
| Address |
govt. ayurvedic medical college, patiala
Patiala
PUNJAB
147001
India |
| Phone |
8630212064 |
| Fax |
|
| Email |
s09608951@gmail.com |
|
|
Source of Monetary or Material Support
|
| govt ayurvedic college and hospital |
|
|
Primary Sponsor
|
| Name |
govt ayurvedic college hospital |
| Address |
opd no. 7
govt. ayurvedic college & hospital
patiala |
| 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 Sangeeta Dev |
govt. ayurvedic college & hospital |
room no. 7 ground floor
OPD of kayachikitsa department
govt. ayurvedic hoapital
Patiala
PUNJAB |
08630212064
s09608951@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional Ethical Committe GRAUP |
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: ATISTHAULYAM (KEVALA-KAPHA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Amritadi guggul, Reference: chakradatt, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 12 Weeks, anupAna/sahapAna: Yes(details: -ushnodak), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Bilwadi kwath, Reference: sharangdhgar samhita,madhyam khand, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 12 Weeks, anupAna/sahapAna: Yes(details: -ushnodak), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. patients with symptoms of sthaulya.
2. BMI greater than 25 kg per meter square upto 39.9kg per meter square.
3. WHR greater than or equals to 0.95 in males and greater then or equals to 0.8 in females.
4. patient of either sex aged between 20 to 60 years. |
|
| ExclusionCriteria |
| Details |
1. BMI more than 40 kg per meter square.
2. known cases of hypothyroidism, diabetes mellitus, cushing syndrome etc.
3. other systemic diseases which interfere with the course of treatment.
4. pregnant and lactating women. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to see the the changes in BMI |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to see changes in WHR, skin fold thickness |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
N/A |
|
Date of First Enrollment (India)
|
31/07/2025 |
| 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="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
A randomized clinical trial was conducted at Govt. ayurvedic college & hospital, patiala, punjab to evaluate the efficacy and safety of two Ayurvedic formulations—Amritadi Guggulu and Bilwadi Kwath—in managing Sthaulya (obesity). The study enrolled 100 participants aged 20 to 60 years, each with a Body Mass Index (BMI) between 25 and 39.9 kg/m². Participants were randomly assigned to two groups: Group I received Amritadi Guggulu (1 gram twice daily before meals), and Group II received Bilwadi Kwath (40 ml twice daily before meals), over a 12-week period. The primary objective was to assess changes in BMI from baseline to 12 weeks. Secondary objectives included evaluating changes in body weight, waist-hip ratio, and skinfold thickness. Subjective symptoms described in Ayurvedic texts, such as Javoparodha (lack of enthusiasm), Kricchra Vyavayata (difficulty in physical activity), and Atisweda (excessive sweating) etc were also monitored. Participants underwent assessments every four weeks, including physical examinations and laboratory investigations like lipid profile, thyroid profile, and random blood sugar levels. The study aimed to provide a safe, cost-effective Ayurvedic treatment for obesity, emphasizing the importance of traditional practices in managing lifestyle disorders. |