| CTRI Number |
CTRI/2023/08/056323 [Registered on: 09/08/2023] Trial Registered Prospectively |
| Last Modified On: |
08/08/2023 |
| 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
|
Effect of Amrutadi Guggul and Tryushnadi Guggul in Sthaulya With special refrence to Obesity |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the efficacy of Amrutadi Guggul and Tryushnadi Guggul in Sthaulya |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vaibhav Raju Badgujar |
| Designation |
P.G Scholar Kayachikitsa |
| Affiliation |
SUMATIBHAI SHAH AYURVED MAHAVIDYALAYA MALWADI HADAPSAR PUNE 411028 |
| Address |
MAMs Sumatibhai Shah Ayurved College Kayachikitsa department OPD No 2 Ground Floor Sane Guruji Arogya Kendra Malwadi Hadapsar Pune Maharashtra
Pune
MAHARASHTRA
411028
India |
| Phone |
8275503463 |
| Fax |
|
| Email |
badgujarvaibhav9076@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sachinkumar Patil |
| Designation |
HOD Department of Kayachikitsa |
| Affiliation |
MAMs SUMATIBHAI SHAH AYURVED MALAVIDYALAYA MALWADI HADAPSAR PUNE |
| Address |
MAMs Sumatibhai Shah Ayurved College Kayachikitsa department OPD No 2 Ground Floor Sane Guruji Arogya Kendra Malwadi Hadapsar Pune Maharashtra
Pune
MAHARASHTRA
411028
India |
| Phone |
9822603608 |
| Fax |
|
| Email |
drsachinkumarpatil@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vaibhav Raju Badgujar |
| Designation |
P.G. Scholar Kayachikitsa |
| Affiliation |
SUMATIBHAI SHAH AYURVED MAHAVIDYALAYA MALWADI HADAPSAR PUNE 411028 |
| Address |
MAMs Sumatibhai Shah Ayurved College Kayachikitsa department OPD No 2 Ground Floor Sane Guruji Arogya Kendra Malwadi Hadapsar Pune Maharashtra
Pune
MAHARASHTRA
411028
India |
| Phone |
8275503463 |
| Fax |
|
| Email |
badgujarvaibhav9076@gmail.com |
|
|
Source of Monetary or Material Support
|
| MAMs Sumatibhai Shah Ayurved College Malwadi Hadapsar Pune 411028 |
|
|
Primary Sponsor
|
| Name |
Dr Vaibhav Raju Badgujar |
| Address |
MAMs Sumatibhai Shah Ayurved College Kayachikitsa department OPD No 2 Ground Floor Sane Guruji Arogya Kendra Malwadi Hadapsar Pune Maharashtra |
| 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 Vaibhav Raju Badgujar |
Sane Guruji Arogya Kendra |
Department of Kayachikitsa OPD N0 2 Ground floor and IPD of Kayachikitsa First Floor Sane Guruji Arogya Kendra Malwadi Hadapsar Pune
Pune
MAHARASHTRA |
8275503463
badgujarvaibhav9076@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAMs SUMATIBHAI SHAH AYURVED MAHAVIDYALAYA AND SANE GURUJI AROGYA KENDRA |
Approved |
|
|
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 | Drug | Classical | | (1) Medicine Name: Amrutadi Guggul, Reference: Vangasena, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -koshna jala), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Tryushnadi Guggul, Reference: Bhavaprakash, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -koshna jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients from age group of 21 to 60 years irrespective of gender, religion, socioeconomic status, marital status.
2) Patients of Sthaulya i.e.as per signs and symptoms BMI >25 to 40.
including overweight Obese Class I,II,III (shown in table 1) an as per signs
and symptoms mentioned in Ayurvedic texts.
3) BMI >25
4) Waist To Hip Ratio more than 1.0
5) Drug induced Obesity e.g. Corticosteroids; anxiolytics; Sulfonylureas; Insulin.
6) Obesity due to excessive calories.
7) Obesity due to lack of Exercise.
8) Skin Fold Thickness(over mid triceps) between 20-24.5mm(in Male) and 28-32mm(in
Female). |
|
| ExclusionCriteria |
| Details |
1) Pregnant women, lactating mother.
2) Acute life threatening conditions like C.V.A., Acute M.I.; Endocrine disorders.
3) B.M.I. > 40.
4) Known Cases of Hypothyroidism.
5)Hormonal imbalanced obesity like PCOD |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of Amrutadi Guggul and Tryushanadi Guggul in Sthaulya. |
0th day 30th day 60th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe the adverse effects of Amrutadi Guggul and Trushanadi Guggul in Sthaulya |
0th day 30th day 60th day |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
11/09/2023 |
| 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 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
|
In present era ,the problems with digestion and obesity are increasing day to day .Due to
sedentary life style , junk food eating ,stress ,lack of exercise ,there are major chances of weight
gain and obesity .
Obesity is defined as abnormal or excessive fat accumulation that present risk to health ,causing
major risk for a number of hypertension, restlessness,fatigue,excess perspiration and lack
cheerfulness. In modern medicine, statins , lipid lowering drugs is only available treatment. It may
cause some adverse effects on cardiac system, renals, bones after long term use.[5]
Previous study was carried out is comparative clinical efficacy of Amrutadi Guggul and Navakadi
Guggul in Sthaulya .
Comparative study of Amrutadi Guggul with Tryushanadi Guggul .In the mentioned study
Amrutadi Guggul turned out to be better drug
Now,this study is being conducted to compare efficacy of both better proven drugs in present
studies with each other to know which is more effect . |