| CTRI Number |
CTRI/2020/02/023193 [Registered on: 07/02/2020] Trial Registered Prospectively |
| Last Modified On: |
27/10/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative clinical study to evaluate the efficacy of
GOMUTRA ARKA BHAVITA SHILAJATU and AGNIMANTHA BHAVITA
SHILAJATU in sthaulya W.S.R. to obesity. |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the efficacy of GOMUTRA ARKA BHAVITA SHILAJATU AND AGNIMANTHA BHAVITA
SHILAJATU 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 Jaypalsing P Pawar |
| Designation |
PG Scholar (Kayachikitsa) |
| Affiliation |
Dr.D.Y.Patil College ofAyurved and Research Center, Pimpri ,Pune 411018. |
| Address |
Dr. D. Y. Patil college of ayurved and research center, kayachikitsa department, pimpri, Pune.
Pune
MAHARASHTRA
411018
India |
| Phone |
9561050500 |
| Fax |
|
| Email |
jaypawar2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jibi T Varghese |
| Designation |
Associate professor (Kayachikitsa) |
| Affiliation |
Dr.D.Y.Patil College ofAyurved and Research Center, Pimpri ,Pune 411018. |
| Address |
Dr.D.Y.Patil college of ayurveda pimpri, kayachikitsa department, pimpri, pune-18
Pune
MAHARASHTRA
411018
India |
| Phone |
8983478062 |
| Fax |
|
| Email |
vjayu82@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jaypalsing P Pawar |
| Designation |
PG Scholar (Kayachikitsa) |
| Affiliation |
Dr.D.Y.Patil College ofAyurved and Research Center, Pimpri ,Pune 411018. |
| Address |
Dr. D. Y. Patil college of ayurved and research center, kayachikitsa department, pimpri, Pune.
Pune
MAHARASHTRA
411018
India |
| Phone |
9561050500 |
| Fax |
|
| Email |
jaypawar2@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. D. Y. Patil college of ayurveda And Research Ceter, Pimpri, Pune-18 |
|
|
Primary Sponsor
|
| Name |
DrDYPatil college of Ayurved and Research centerPimpriPune |
| Address |
sant tukaram nagar, Pimpri, pune-18 |
| 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 |
| Drjaypalsing |
Dr. D. Y. Patil college of Ayurveda and research center |
Dr. D. Y. Patil college of ayurved and research center, kayachikitsa department, pimpri, Pune.
Pune
MAHARASHTRA |
9561050500
jaypawar2@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 |
| Healthy Human Volunteers |
Patients health condition has to be good. Patient does not have any hypertensive or thyroid diseases history. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
AGNIMANTHA BHAVITA SHILAJATU |
Dose-500 mg TWICE in a day
before food by ORALLY for 30days |
| Intervention |
GOMUTRA ARKA BHAVITA SHILAJATU |
Dose-500 mg TWICE in a day
before food by ORALLY for 30days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients of age group 18 to 60 years.
2) Body Mass Index (BMI) >25 kg/m2
to 40 kg/m2
3) Gender: Both (Male and female)
4) Willing and able to participate in the study for 30 days.
5) Patient selection will be irrespective of season and prakriti also. |
|
| ExclusionCriteria |
| Details |
1) The patient having B.M.I. (Body mass index) below 25.
2) Pregnant and lactating women.
3) Sthaulya (Obese) patients having genetic cause (Beeja Dosha).
4) Sthaulya (Obese) patients having cardiac complications,
diabetes mellitus, malignancy and hormonal problems like
thyroids. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to reduce obesity and its complications |
The time period for observation is 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To improve the lifestyle of patient |
30 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "68"
Final Enrollment numbers achieved (India)="68" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
07/02/2020 |
| Date of Study Completion (India) |
07/03/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
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)?
|
Brief Summary
Modification(s)
|
The study will be condudted in 2 groups. Group A) Gomutra arka bhavita shilajatu & Group B) Agnimantha bhavita shilajatu. Both the group of patients medicine will be given for 30 days and follow up will be taken and results will be done using proper statistical methods.
32 patients were enrolled with Gomutra Arka bhavita Shilajatu and 32 patients were enrolled with Agnimanthabhavita Shilajatu.
Gomutra arka bhavita shilajatu was found comparatively more effective as compared with Agnimantha bhavita Shilajatu. Gomutra Arka bhavita Shilajatu was found statastically more effective in subjective and objective parameters than Agnimanthabhavita Shilajatu.
|