| CTRI Number |
CTRI/2020/09/027508 [Registered on: 01/09/2020] Trial Registered Prospectively |
| Last Modified On: |
18/08/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical Trial To Study The Effect Of Ayurvedic Medication On Sthoulya (obesity) |
|
Scientific Title of Study
|
“Nidanatmaka study of Medoroga (Adiposopathy) and Upashayatmaka Randomised trial of Nyagrodhadi Ghanavati and Navaka Guggulu†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bhagya Ranjan Dash |
| Designation |
PhD Scholar |
| Affiliation |
NIA, JAIPUR, RAJASTHAN |
| Address |
PG Department Of Roga Nidana Evam Vikriti Vigyan, National Institute of
Ayurveda, Madhav Villas Palace, Jorawar Singh Gate, Amer road
Jaipur
RAJASTHAN
302002
India |
| Phone |
7018229414 |
| Fax |
|
| Email |
drbhagyaranjan86@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pawankumar Godatwar |
| Designation |
HOD and Professor |
| Affiliation |
NIA, JAIPUR, RAJASTHAN |
| Address |
PG Department Of Roga Nidana Evam Vikriti Vigyan,PG Department Of Roga Nidana Evam Vikriti Vigyan, National Institute of
Ayurveda, Madhav Villas Palace, Jorawar Singh Gate, Amer road
Jaipur
RAJASTHAN
302002
India |
| Phone |
9314502834 |
| Fax |
|
| Email |
pgodatwar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhagya Ranjan Dash |
| Designation |
PhD Scholar |
| Affiliation |
NIA, JAIPUR, RAJASTHAN |
| Address |
PG Department Of Roga Nidana Evam Vikriti Vigyan, PG Department Of Roga Nidana Evam Vikriti Vigyan, National Institute of
Ayurveda, Madhav Villas Palace, Jorawar Singh Gate, Amer road
Jaipur
RAJASTHAN
302002
India |
| Phone |
7018229414 |
| Fax |
|
| Email |
drbhagyaranjan86@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute Of Ayurveda, Jaipur, Rajasthan |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda |
| Address |
PG Deptt. Of Roga Nidana Evam Vikrati Vigyan,National Institute of
Ayurveda, Jorawar Singh Gate Madhav Vilas Palace, Amer Road
Jaipur
RAJASTHAN
302002
India |
| 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 |
| BHAGYA RANJAN DASH |
National institute of Ayurveda |
PG Department Of Roga Nidana Evam Vikriti Vigyan, OPD number 6 &17
Jaipur
RAJASTHAN |
7018229414
drbhagyaranjan86@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC NATIONAL INSTITUTE OF AYURVEDA |
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 Guggulu |
500mg tablet will be given orally, twice daily, before food, with warm water, for a duration of 90 days |
| Intervention |
Nyagrodhadi Ghanavati |
500mg tablet will be given orally, twice daily, before food, with warm water, for a duration of 90 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects with LDL-C ≥ 130(mg/dl) at the time of screening.
2. Subjects with BMI ≥24
3. Subjects willing to follow the procedures as per the study protocol and voluntarily give written informed consent.
|
|
| ExclusionCriteria |
| Details |
1. Subjects with Diabetes Mellitus Type I and uncontrolled Diabetes Mellitus Type II.
2. Subjects with uncontrolled Hypothyroidism or Hyperthyroidism
3. Known cases of Severe/Chronic Hepatic or Renal disease
4. Known subject of any active malignancy.
5. Subjects giving history of significant cardiovascular event < 12 weeks prior to randomization.
6. Known case of Anorexia Nervosa or Bulimia nervosa
7. Chronic alcoholics / Alcohol Abuse
8. Subjects ECG demonstrating any signs of uncontrolled arrhythmia / acute ischemia.
9. Subjects X- ray chest showing any active lesion of tuberculosis
10. Subjects having known chronic, contagious infectious disease, such as active tuberculosis Hepatitis B or C, or HIV.
11. Subjects using any other investigational drug within 1 month prior to recruitment
12. Known hypersensitivity to any of the ingredients used in study drug
13. Pregnant and Lactating females.
15. Subjects currently participating in any other Clinical study
16. Any other medical or surgical condition considered unsuitable for subject participation in the study as per Investigator’s judgment.
|
|
|
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 |
1.Change in LDL-C level at the end of study
2.Change in body weight at the end of study
|
Baseline, 6th Week, 12th Week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Change in LDL-C level at 6 weeks
2.Change in other lipid parameters such as Triglycerides (TG), Total Cholesterol (TC) and High Density Lipoprotein (HDL) at 6 weeks and 12 weeks.
3.Change in Body Weight, BMI, Waist circumference and Waist to hip ratio at 6 weeks and 12 weeks.
|
Baseline, 6th Week, 12th Week |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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 |
|
Date of First Enrollment (India)
|
20/09/2020 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NOT YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The objectives of this prospective cohort study (provisional sample size 200 urban patients) are (a) Generation of cross sectional data on Prakriti, body composition, presence of adipocytokines flux / hematologic markers in peripheral blood, ectopic lipid deposition, insulin resistance and clinical/biochemical parameters of diabetes, hypertension, dyslipidemia and atherosclerotic vascular disease in members of Jaipur families at high risk of T2DM. (b) application of data so generated in development of a staging system of Medoroga - dysmetabolism (adiposopathy/sick fat, allopath equivalent of Medo Roga), (c) study effect of Nyagrodhadi Ghana vati and Medohara guggulu on Medoroga -dysmetabolism (parameters of adiposopathy). |