| CTRI Number |
CTRI/2024/12/078751 [Registered on: 30/12/2024] Trial Registered Prospectively |
| Last Modified On: |
27/12/2024 |
| 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
|
This study compares two ayurvedic treatment for obesity one with triphala guggulu with varunadi kvatha and the other kanchnara guggulu with mustadi kvatha to see which works better |
|
Scientific Title of Study
|
Clinico–Comparative Study Of Triphala Guggulu With Varunadi Kvatha Versus Kanchanara guggulu With Mustadi Kvatha In The Management Of Sthaulya (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 Sanket Chandrakantbhai Kasundra |
| Designation |
PG Scholar |
| Affiliation |
J S Ayurveda Mahavidhyalaya and P D Patel Ayurveda Hospital |
| Address |
PG Department of kayachikitsa js ayurveda mahavidhyalaya college road nadiad
kheda
gujarat
387001
india
1 J S Ayurveda Mahavidhyalaya
college road
Nadiad 387001
Dist Kheda
Gujarat
India
Kheda
GUJARAT
387001
India |
| Phone |
7434800627 |
| Fax |
|
| Email |
drsanketkasundra98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Kalapi B Patel |
| Designation |
professor and HOD Department of Panchakarma |
| Affiliation |
P D Patel Ayurvedic Hospital J S Ayurved Mahavidyalay |
| Address |
PG Department of Panchakarma js ayurveda mahavidhyalaya college road nadiad
kheda
gujarat
387001
india
Kheda
GUJARAT
387001
India |
| Phone |
9428661664 |
| Fax |
|
| Email |
drkalapi@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Kalapi B Patel |
| Designation |
professor and HOD Department of Panchakarma |
| Affiliation |
P D Patel Ayurvedic Hospital J S Ayurved Mahavidyalay |
| Address |
PG Department of Panchakarma js ayurveda mahavidhyalaya college road nadiad
kheda
gujarat
387001
india
GUJARAT
387001
India |
| Phone |
9428661664 |
| Fax |
|
| Email |
drkalapi@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| 1 Sundar Ayurveda Teaching Pharmacy of J S Ayurveda Mahavidyalaya
College road
Nadiad 387001
Dist Kheda
Gujarat
India |
|
|
Primary Sponsor
|
| Name |
J S Ayurved Mahavidyalaya |
| Address |
J S Ayurved Mahavidyalaya college road nadiad 387001 |
| Type of Sponsor |
Private 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 sanket chandrakant kasundra |
P D Patel Ayurveda Hospital |
PG Department of Kaychikitsa
Room no. 101 and 102 P D Patel
Ayurved hospital J S
Ayurveda college
campus college Road
Nadiad 387001
Kheda
GUJARAT
Kheda
GUJARAT |
7434800627
drsanketkasundra98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITEE FOR HUMAN RESEARCH |
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: Kanchnara guggulu, Reference: Sarangdhar samhita by Sarangadharacharya, Dipika hindicommentary, Madhyamkhad Vatakakalpana adhayay 7/98-100, edited by Brahmanand Tripathy, Chaukhamba Surbharati Prakashan Varanasi, 2004, 207, Route: Oral, Dosage Form: Guggulu , Dose: 900(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 8 Weeks, anupAna/sahapAna: Yes(details: Ushnodaka), Additional Information: -(2) Medicine Name: Mustadi kvatha, Reference: Charaka samhita chakrapaniteeka Sutrasthana adhyay Ashtauninditiya Adhyaya 23/12-13 page no.122(chaukhambhasurbharatiprakashan prologue by Prof. R.H. Singh, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 8 Weeks, anupAna/sahapAna: No, Additional Information: | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Triphala gugglu, Reference: Sharangdhar Samhita by Dr. SailajaJivanpradavyakhya Published by Chaukhambha Orientala 2011, Varanasi, Madhyakhanda 7/83-84, Page no. 205. , Route: Oral, Dosage Form: Guggulu , Dose: 900(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 8 Weeks, anupAna/sahapAna: Yes(details: Ushnodaka), Additional Information: -(2) Medicine Name: Varunadi kvatha, Reference: Govinddas Sen. In: BhaishajyaRatnavali, GulmaChikitsa, Adhyaya 32/38 to 40.11th ed. Mishra Brahmashankara, editor. Varanasi: Chaukhambha Sanskrit Sansthan; 1993. , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 8 Weeks, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1)Age between 18 to 50 years.
2)Patient fulfilling the diagnostic criteria of sthaulya (obesity).
|
|
| ExclusionCriteria |
| Details |
1)Patients having any cardiac, renal, liver problems or other chronic co-morbidities.
2)Patients having hypothyroidism.
3)Patients who have taken corticosteroids in last 6 months.
4)Pregnant women & lactating mothers.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of Triphala Guggulu with Varunadi Kvatha versus Kanchanar Guggulu with Mustadi Kvatha in managment of Sthaulya |
4th weeks and
8th weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in BMI & waist to hip ratio of obesity patient |
4th week &
8th week |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
11/01/2025 |
| 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
|
Overweight and obesity are defined as abnormal or excessive fat accumulation that presents a risk to health. A person with a BMI of 30 or more is generally considered obese. A person with a BMI equal to or more than 25 is considered over weight.MustÄdikvÄtha is mentioned in charaka samhita and also indicated in the Sthaulya roga.iii KÄñcanÄraguggulu is also indicated for MÄá¹sa and Medoduá¹£á¹i related disorders.iv The effect of oral administration of TriphalÄguggulu and VarūṇÄdikvÄtha together in the management of Sthaulya (obesity) has been proved effective scientifically and the articles related its results were already published in various scientific peer reviewed journals.The aim of the study is to observe the effect of the treatment separately in the patients of both the groups. |