| CTRI Number |
CTRI/2020/02/023463 [Registered on: 20/02/2020] Trial Registered Prospectively |
| Last Modified On: |
19/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficacy of Pippali Churna in Gridhrasi |
|
Scientific Title of Study
|
Randomized Control Clinical Trial Of Pippali Churna in Gridhrasi |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pooja Ajit Ambekar |
| Designation |
PG Scholar Kayachikitsa |
| Affiliation |
Hon.Shree Annasaheb Dange Ayurvedic Medical College and post graduation research centre,ashta |
| Address |
Hon.Shree Annasaheb Dange Ayurved Medical College And Postgraduation Research Centre Ashta
Sangli
MAHARASHTRA
416301
India |
| Phone |
7709362730 |
| Fax |
|
| Email |
poojaambekar1994@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrParag Narayan Deshmukhe |
| Designation |
Professor |
| Affiliation |
Hon.Shree Annasaheb Dange Ayurvedic Medical College and post graduation research centre,ashta |
| Address |
Hon.Shree Annasaheb Dange Ayurved Medical College And Postgraduation Research Centre Ashta
Sangli
MAHARASHTRA
416301
India |
| Phone |
7719954457 |
| Fax |
|
| Email |
pdeshmukhe@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Pooja Ajit Ambekar |
| Designation |
PG Scholar Kayachikitsa |
| Affiliation |
Hon.Shree Annasaheb Dange Ayurvedic Medical College and post graduation research centre,ashta |
| Address |
Hon.Shree Annasaheb Dange Ayurved Medical College And Postgraduation Research Centre Ashta
Sangli
MAHARASHTRA
416301
India |
| Phone |
7709362730 |
| Fax |
|
| Email |
poojaambekar1994@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon.Shree Annasaheb Dange Ayurvedic Medical College and Post graduation research centre Ashta. |
|
|
Primary Sponsor
|
| Name |
HonShree Annasaheb Dange Ayurved Medical College And Postgraduation Research Centre Ashta |
| Address |
Hon.Shree Annasaheb Dange Ayurved Medical College And Post graduation Research Centre Ashta |
| 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 |
| Pooja Ajit Ambekar |
Hon.Shree Annasaheb Dange Ayurved Medical College And Post Graduation Research Centre Ashta |
Hon.Shree Annasaheb Dange Ayurved Medical College And Post Graduation Research Centre Ashta
Sangli
MAHARASHTRA |
7709362730
poojaambekar1994@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: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ajmodadi Churna |
Ajmodadi Churna 1gm BD |
| Intervention |
Pippali Churna in Grudhreasi |
Pippali Churna 250mg BD along with Eranda Taila 20ml and Gomutra 10ml for 28 days |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with clinical symptoms like Ruka (Referred pain from sphika to Pada Pradesh)Toda, Stambha,Spandana |
|
| ExclusionCriteria |
| Details |
1)Previously diagnosed Congenital abnormalities in lumbar spine
2)Operated for spinal disease
3)Pregnancy
4)Previously Diagnosed T.B.of Spine
5)Accidental trauma |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the efficacy of Pippali Churna in Gridhrasi |
24weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To review literature on Gridhradi |
Nil |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
22/02/2020 |
| 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="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)?
Response - NO
|
|
Brief Summary
|
I am Pooja Ajit Ambekar PG Scholar trying to evaluate the efficacy of Pippali Churna in Gridhrasi.Data will be drawn from 64 patients.As in modern medicine the choice of treatment is NSAIDs only hence to avoid side effects there is need of ayurvedic medicine. |