| CTRI Number |
CTRI/2019/09/021354 [Registered on: 20/09/2019] Trial Registered Prospectively |
| Last Modified On: |
19/09/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Preparation of Abha Guggulu using Abha Phala, Analysis of the prepared medicine,and trial of prepared Abha guggulu on the patients of janusandhigatavata.(osteoarthritis of knee) |
|
Scientific Title of Study
|
Pharmaceutical,Analytical study and Exploratory Clinical Evaluation of Abha Guggulu prepared using Abha phala in Janusandhigatavata |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mrinmayee Hedaoo |
| Designation |
BAMS |
| Affiliation |
BVDU College Of Ayurved |
| Address |
Bharati Vidyapeeth (Deemed To Be) University, College of Ayurved and Hospital,Kayachikitsa Dept.OPD no.3,Ground floor.
Katraj,Pune-411043
BV(DU)College Of Ayurved and HospitalKayachikitsa dept,OPD no.3,Katraj,Pune-411043
Pune
MAHARASHTRA
411043
India |
| Phone |
9922086676 |
| Fax |
|
| Email |
mrinmayeehedaoo@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrinmayee Hedaoo |
| Designation |
BAMS |
| Affiliation |
BVDU College Of Ayurved |
| Address |
BV(DU)College of Ayurved and Hospital,Kayachikitsa Dept.OPD no.3,Katraj,Pune-411043
BV(DU)College Of Ayurved and Hospital,Kayachikitsa Dept.OPD no.3,Katraj,Pune-411043
Pune
MAHARASHTRA
411043
India |
| Phone |
9922086676 |
| Fax |
|
| Email |
mrinmayeehedaoo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mrinmayee Hedaoo |
| Designation |
BAMS |
| Affiliation |
BVDU College Of Ayurved |
| Address |
BV(DU)College Of Ayurved and Hospital,Kayachikitsa dept.OPD no 3,Katraj,Pune-411043
BV(DU)College of Ayurved Hospital,Kayachikitsa dept.OPD no 3,,Katraj,Pune-411043
Pune
MAHARASHTRA
411043
India |
| Phone |
9922086676 |
| Fax |
|
| Email |
mrinmayeehedaoo@gmail.com |
|
|
Source of Monetary or Material Support
|
| BV(DU)COLLEGE OF AYURVEDA and HOSPITAL,KATRAJ,PUNE-411043 |
|
|
Primary Sponsor
|
| Name |
DrMrinmayee Hedaoo |
| Address |
BV(DU) College of Ayurved and Hospital,Kayachikitsa dept.OPD no-3,Katraj,Pune-411043 |
| Type of Sponsor |
Other [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 |
| DrTrupti Patil Bhole |
College of Ayurved and Hospital,Bharati Vidyapeeth (Deemed To Be) University,Pune |
Kayachikitsa Department,Ground floor,BV(DU)College of Ayurved and Hospital.
Pune
MAHARASHTRA |
9822316623
truptibhole@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BV(DU)COA-EC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ABHA GUGGULU TABLETS |
ABHA GUGGULU 3GMS/DAY IN TWO DIVIDED DOSES FOR 1 MONTH |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients having signs and symptoms of sandhigatav vata affecting janu.
2.All economic strata and prakruti. |
|
| ExclusionCriteria |
| Details |
1.Patients with Rheumatoid Arthritis
2.Uncontrolled Hypertension
3.Diseases like paralysis,parkinsons disease,severe anaemia,cancer.
4.secondary osteoarthritis due to tuberculosis,AIDS. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| reduction in disease severity as seen in WOMAC scale |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| reduction in disease severity as seen in WOMAC scale |
30 days |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
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)
|
30/10/2019 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This will be an exploratory clinical trial to check the efficacy of Abha Guggulu manufactured using Abha phala, in patients suffering from Knee joint OA. |