| CTRI Number |
CTRI/2024/10/074859 [Registered on: 07/10/2024] Trial Registered Prospectively |
| Last Modified On: |
04/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A trial to study the comparison of matrabasti with sahachar taila and swadamstradi taila in gridhrasi |
|
Scientific Title of Study
|
Randomized controlled clinical trial to study the comparative efficacy of matra basti with sahachar taila and swadamstradi taila in management of gridhrasi |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mayuri Bharatkumar Kumbhar |
| Designation |
PG Scholar |
| Affiliation |
Tilak Ayurved Mahavidyalaya |
| Address |
OPD no.13,Department Of Panchakarma,Seth Tarachand Ramnath Charitable Hospital,Vaidya Nanal Shashtri Street,Rasta Peth,Pune 411011, Maharashtra,India
OPD no.13,Department Of Panchakarma,Tilak Ayurved Mahavidyalaya,Rasta peth,Pune 411011, Maharashtra, India
Pune
MAHARASHTRA
411011
India |
| Phone |
9960227738 |
| Fax |
|
| Email |
kumbharmayuri1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rajendra S Huparikar |
| Designation |
M.D.,Ph.D.,Head of Department (Panchakarma) |
| Affiliation |
Tilak Ayurved Mahavidyalaya |
| Address |
OPD no.13,Department of Panchakarma,Tilak Ayurved Mahavidyalaya,Rasta peth,Pune 411011, Maharashtra, India
OPD no.13,Department of Panchakarma,Seth Tarachand Ramnath Charitable Hospital,Vaidya Nanal Shashtri Street,Rasta Peth,Pune-411011, Maharashtra,India
Pune
MAHARASHTRA
411011
India |
| Phone |
9823050402 |
| Fax |
|
| Email |
ayurvedapune@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mayuri Bharatkumar Kumbhar |
| Designation |
PG Scholar |
| Affiliation |
Tilak Ayurved Mahavidyalaya |
| Address |
Opd no.13,Department of Panchakarma,Tilak Ayurved Mahavidyalaya,Rasta peth,Pune 411011, Maharashtra, India
Opd no.13,Department of Panchakarma,Seth Tarachand Ramnath Charitable Hospital,Vaidya Nanal Shashtri Street,Rasta Peth,Pune-411011, Maharashtra,India
Pune
MAHARASHTRA
411011
India |
| Phone |
9823050402 |
| Fax |
|
| Email |
ayurvedapune@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tilak Ayurved Mahavidyalaya and Seth Tarachand Ramnath Charitable Ayurved Hospital,Rasta Peth,Pune-411011,Maharashtra,India |
|
|
Primary Sponsor
|
| Name |
Tilak Ayurved Mahavidyalaya |
| Address |
Tilak Ayurved Mahavidyalaya,Rasta Peth,Pune 411011,Maharashtra,India |
| Type of Sponsor |
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 |
| DrMayuri Bharatkumar Kumbhar |
Seth Tarachand Ramnath Charitable Hospital, |
OPD no. 13,Department of Panchakarma,Vaidya Nanal Shashtri Street,Rasta Peth,Pune 411011
Pune
MAHARASHTRA |
9960227738
kumbharmayuri1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tilak Ayurved Mahavidyalaya and Seth Tarachand Ramnath Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M544||Lumbago with sciatica, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Matrabasti in management of gridhrasi |
Matrabasti with sahachar taila - 60 ml for 7 days in management of gridhrasi
|
| Comparator Agent |
Matrabasti in management of gridhrasi |
Swadamstradi taila matrabasti -60 ml for 7 days in management of gridhrasi |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient with age group 30-70 years
2.Diseases described in ayurvedic text as basti arha
3.Patients having minimum 3 signs and symptoms of gridhrasi i.e. sphikpurva katiprushtajanujanghapadam kramat,stambha,toda,graha,grudhravatchalan,gaurava |
|
| ExclusionCriteria |
| Details |
1.Patients who are mentioned as basti-anarha
2.Auto immune diseases like SLE,Ankylosing Spondylosis
3.Having severe crippling deformity
4.Patients having Spinal deformities,severe taumatic injury to spinal cord and having unbearable pain
5.Kniwn cases of Pulmonary TB,cardiac diseases,HIV,HbsAg.
6.Patientsbelonging to age group below 20 and above 70 years
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparative Efficacy of Matra basti with sahachar taila and swadamstradi taila in management og gridhrasi |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Study adverse effects of sahachar taila and swadamstradi taila if any |
18 months |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
30/10/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Clinically evaluate and compare the effect of sahachar taila matrabasti and swadamstradi taila matrabasti in management of gridhrasi. Study the adverse effects of sahachar taila and swadamstradi taila if any Study the role of basti chikitsa in gridhrasi |