| CTRI Number |
CTRI/2020/08/027376 [Registered on: 26/08/2020] Trial Registered Prospectively |
| Last Modified On: |
07/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic
Preventive
Screening |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Management of Sthoulya with Ayuvedic medicine |
|
Scientific Title of Study
|
Comparative clinical efficacy of Tryushanadi guggul and Navaka guggul in Sthoulya (Overweight) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashvini Dinesh Pardhekar |
| Designation |
PG Scholar |
| Affiliation |
Datta Meghe Institute of Medical Sciences Deemed to be University Wardha |
| Address |
Datta Meghe Institute of Medical Sciences Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Hirapur Wardha 442001
OPD and IPD of Kayachikitsa Department room number 30
Wardha
MAHARASHTRA
442001
India |
| Phone |
8329737457 |
| Fax |
|
| Email |
ashupardhekar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrVinod Ade |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Medical Sciences Deemed to be University Wardha |
| Address |
Datta Meghe Institute of Medical Sciences Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Hirapur Wardha 442001
OPD and IPD of Kayachikitsa Department room number 30
Wardha
MAHARASHTRA
442001
India |
| Phone |
9689365368 |
| Fax |
|
| Email |
dr.vinodade@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ashvini Dinesh Pardhekar |
| Designation |
PG Scholar |
| Affiliation |
Datta Meghe Institute of Medical Sciences Deemed to be University Wardha |
| Address |
Datta Meghe Institute of Medical Sciences Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Hirapur Wardha 442001
OPD and IPD of Kayachikitsa Department room number 30
Wardha
MAHARASHTRA
442001
India |
| Phone |
8329737457 |
| Fax |
|
| Email |
ashupardhekar@gmail.com |
|
|
Source of Monetary or Material Support
|
| The subjects will be recruited from Kayachikitsa OPD and IPD of Mahatma Gandhi Ayurved College Hospital snd Research Centre Salod Hirapur Wardha and special multidiagnostic Camp |
|
|
Primary Sponsor
|
| Name |
Ashvini Dinesh Pardhekar |
| Address |
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Hirapur Wardha 442001 |
| 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 |
| Ashvini Dinesh Pardhekar |
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Hirapur Wardha 442001 |
OPD and IPD of Department of Kayachikitsa Room No 30
Wardha
MAHARASHTRA |
8329737457
ashupardhekar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E663||Overweight, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Navaka guggul |
Contains Sunthi,Marich,Pippali,Chitrak,Haritaki,Vibhitaki,Amlaki,Musta,Vidanga,Shudha Guggul Dose will be 1 gm Twice a day after meal with Honey for 30vdays |
| Intervention |
Tryushanai guggul |
Contain Sunthi,Marich,Pippali,Chitrak,Musta,Vidang,Vaca,Shudha Guggul Dose will be 1 gm Twice a day with Honey after meal for 30 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with features of Sthoulya like Ayasenshwasa,Swedadhikya,Atikshudha,Nidradhikya,BMI between 25-30 Kg/m2 |
|
| ExclusionCriteria |
| Details |
BMI more than 30 Kg/m2,BMI betwwn 25-30 Kg/m2 with increased lipid level or on medication for Dyslipidemia,K/c/o Hypothyroidism,Diabetes Mellitus,Cardiovascular and Renal disorder,Drug Induced Obesity,Pregnent and Lactating women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief from symptoms of Ayasenshwas,Swedadhikya,Atikshudha,Nidradhikya by standard gradation and BMI,Weight,Mid arm cicumference,Waist-Hip Ratio decreses |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Serum Lipid Profile get Decrease |
30 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
29/08/2020 |
| Date of Study Completion (India) |
30/06/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is single blind randomised controlled trial comparing the clinical efficacy of Tryushanadi Guggul 1gm twice a day with Honey after meal and Navaka guggul 1 gm twice a day with Honey after meal for 30 days in 60 patient(30 patient in each group),the ptimary outcome will measure by gradation,weighing machine,Tailor tape,Vernier caliper and secondary outcome by laboratory Investigation before and after completion of treatment duration. |