| CTRI Number |
CTRI/2019/03/018149 [Registered on: 18/03/2019] Trial Registered Prospectively |
| Last Modified On: |
06/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Navaka guggulu and Rasanjana ghanvati in Sthaulya |
|
Scientific Title of Study
|
A comparative pharmaceutico analytical and clinical study of navaka guggulu and rasanjana ghanvati in sthaulya w.s.r to obesity |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Usha Sharma |
| Designation |
Associate Professor |
| Affiliation |
Department of Rasa Shatra & Bhaishajya Kalpana Rishikul campus, U.A.U, Haridwar |
| Address |
Department of Rasa Shatra & Bhaishajya Kalpana Rishikul campus, U.A.U, Haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9219618264 |
| Fax |
|
| Email |
ushaojha62@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Usha Sharma |
| Designation |
Associate Professor |
| Affiliation |
Department of Rasa Shatra & Bhaishajya Kalpana Rishikul campus, U.A.U, Haridwar |
| Address |
Department of Rasa Shatra & Bhaishajya Kalpana Rishikul campus, U.A.U, Haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9219618264 |
| Fax |
|
| Email |
ushaojha62@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Usha Sharma |
| Designation |
Associate Professor |
| Affiliation |
Department of Rasa Shatra & Bhaishajya Kalpana Rishikul campus, U.A.U, Haridwar |
| Address |
Department of Rasa Shatra & Bhaishajya Kalpana Rishikul campus, U.A.U, Haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9219618264 |
| Fax |
|
| Email |
ushaojha62@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rishikul Campus, U.A.U. Hariwar |
|
|
Primary Sponsor
|
| Name |
Rishikul Campus |
| Address |
Department of Rasa Shatra & Bhaishajya Kalpana Rishikul campus, U.A.U, Haridwar |
| 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 |
| julika |
OPD and IPD of Rishikul Govt. P.G. Ayurvedic College & Hospital, Haridwar |
Department of Rasa Shatra & Bhaishajya Kalpana Rishikul Campus, U.A.U, Haridwar
Hardwar
UTTARANCHAL |
09649911486
julikadang1993@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: K929||Disease of digestive system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A |
Navaka Guggulu 1gm TDS for 90 Days |
| Comparator Agent |
Group B |
Rasanjana Ghanvati 500mg TDS for 90 Days |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. clinical signs and symptoms of sthaulya.
2. bmi> 25kg/square meter
|
|
| ExclusionCriteria |
| Details |
1. patient with hypothyroidism and cushing syndrome
2. patient with long term steroid treatment
3. patient with severe hypertension.
4. patient with evidence of renal, hepatic and cardiac involvement
5. patient with DM. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
It will be carried out at interval of 30 Days till completion of trial(90 days)
2. will be carried out before , during and after the treatment.
3. Assessment will be done statistically.
4. Any addition or exclusion may be included as per necessity of the study. |
It will be carried out at interval of 30 Days till completion of trial(90 days)
2. will be carried out before , during and after the treatment.
3. Assessment will be done statistically.
4. Any addition or exclusion may be included as per necessity of the study. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| exacaberation in signs and symptoms |
1 month |
|
|
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)
|
25/03/2019 |
| 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="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
Trial yet not to be completed. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The Study main purpose is to Compare and evaluate the clinical efficacy of Navaka guggulu and Rasanjana ghanvati in the management of sthaulya and Assessment will be done statistically.trail yet not to be completed. |