| CTRI Number |
CTRI/2019/03/018256 [Registered on: 25/03/2019] Trial Registered Prospectively |
| Last Modified On: |
25/03/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparison of Haridradi ghana and Medohara guggulu in sthaulya. |
|
Scientific Title of Study
|
A standard controlled clinical study of haridradi ghana and medohara guggulu in the management of sthaulya. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Asmita Namdeo Satkar |
| Designation |
PG Student |
| Affiliation |
PDEAs college of ayurved and rersearch centre akurdi pune |
| Address |
PDEAs college of ayurved and research centre akurdi sect 25 pune
ayurved rugnalay and sterling multispeciality hospital sect 27 nigdi pradhikarn pune 44
Pune
MAHARASHTRA
411044
India |
| Phone |
9527959277 |
| Fax |
|
| Email |
satkarasmita2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Medha Mahesh Joshi |
| Designation |
HOD and Guide dept of Kaychikitsa |
| Affiliation |
PDEAs college of ayurved and research centre akurdi |
| Address |
PDEAs college of ayurved and research centre akurdi sect 25 pune
ayurved rugnalay and sterling multispeciality hospital sect 27 nigdi pradhikarn pune 44
Pune
MAHARASHTRA
411044
India |
| Phone |
9881465798 |
| Fax |
|
| Email |
medhamaheshjoshi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Asmita Namdeo Satkar |
| Designation |
PG Student |
| Affiliation |
PDEAs college of ayurved and research centre akurdi |
| Address |
PDEAs college of ayurved and research centre akurdi sect 25 pune
ayurved rugnalay and sterling multispeciality hospital sect 27 nigdi pradhikarn pune 44
Pune
MAHARASHTRA
411044
India |
| Phone |
9527959277 |
| Fax |
|
| Email |
satkarasmita2@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs college of ayurved and research centre 3rd floor kayachikitsa department Akurdi Pune Nigadi pradhikaran sector no 25 pune 44. |
|
|
Primary Sponsor
|
| Name |
CARC Nigdi pune |
| Address |
PDEAs college of ayurved and research centre akurdi sect 25 pune 44 |
| 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 Asmita Namdeo Satkar |
Ayurved rugnalay and sterling multispeciality hospital nigdi pune |
vithhal rukhmini road sector 27 nigdi pradhikaran 411044 name of opd kayachikitsa number of opd -117 on ground floor nigdi pune maharashtra
Pune
MAHARASHTRA |
9527959277
satkarasmita2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E669||Obesity, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Haridradi ghana |
Haridradi ghana is prepared by Ghana kalpna and will be given orally in the age group 20-60 years.the tablet is given in the dose of 500 mg twice aday before meal with luke warm water which includes follow up on 30th,60th,90th day. |
| Comparator Agent |
Medohara guggulu |
Medohara guggulu will be purchased from GMP certified pharmacy and will be given orally in the age group 20-60 years.the tablet is given in the dose of 500 mg twice aday before meal with luke warm water which includes follow up on 30th,60th,90th day. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.patients who are having 2 or more following symptoms will be included
a.kshudrashwas
b.atitrishna
c.angasaad
d.atikshudha
e.medomansativridhi
d.sphik,stana.udar lambanam etc
2.BMI 25 TO 30 KG/m2 |
|
| ExclusionCriteria |
| Details |
1.k/c/o of renal involvement ,IHD
2k/c/o hypothyroidism,other endocrinal disorders
3 patient who are on long term steroid treatment
4 pregnant and lactating females |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the role Haridradi Ghana and Medohara guggulu in the management of sthaulya. |
90 days with follow up on 30th,60th,90th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1To compare and study the efficacy of haridradi ghana
2To compare and study the efficacy ofmedohara guggulu
3 to study the adverse effect if any |
90 days |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 1/ Phase 2 |
|
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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Being overweight is common problem of todays era. people generally considered obese when BMI is above 25kg/m2. causes of obesity are life style changes,sedentary life style adption,change in food habits like excessive consumption of fast food or packed food which are having added preservatives and sugar,lack of physical activity, mental stress,endocrinal disordrs . According to WHO overweight and obese are amlong five leading causes of death globally. according to ayurved meda,kapha,vata are mainly responsible in the pathogenesis of sthaulya therefor medoghna,kaphaghna and vataghna properties of drug will be used for treatment of sthaulya. the main objective of this research work is to provide consolidated report on traditional uses of medoghna property of haridradi ghana and medohara guggulu in the management of sthaulya. |