| CTRI Number |
CTRI/2025/05/087432 [Registered on: 22/05/2025] Trial Registered Prospectively |
| Last Modified On: |
20/05/2025 |
| 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
|
To study the adjuvant effect of core muscle strengthening excercise and sahachar taila matra basti |
|
Scientific Title of Study
|
A Randomised controlled clinical trial to study the effect of sahachar tail matrabasti with core muscle strengthening exercise in gridhrasi with special reference to sciatica |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kaustubh Avinash Muley |
| Designation |
PG Student |
| Affiliation |
SMBT Ayurved College and Hospital |
| Address |
1 Swarsangam Navshakti Chowk Bhabhanagar Mumbai naka nashik
SMBT Ayurved College, Nandi hills, Dhamangaon, Igatpuri, Nashik
Nashik
MAHARASHTRA
422011
India |
| Phone |
9834310443 |
| Fax |
|
| Email |
rangeralone451@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rashmi Kurawar |
| Designation |
Associate Professor |
| Affiliation |
SMBT Ayurved College and Hospital |
| Address |
SMBT Ayurved College, Nandi hills Dhamangaon Igatpuri Nashik
SMBT Ayurved College, Nandi hills Dhamangaon Igatpuri Nashik
Nashik
MAHARASHTRA
422403
India |
| Phone |
8793655354 |
| Fax |
|
| Email |
rashmikurawar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rashmi Kurawar |
| Designation |
Associate Professor |
| Affiliation |
SMBT Ayurved College and Hospital |
| Address |
SMBT Ayurved College, Nandi hills Dhamangaon Igatpuri Nashik
SMBT Ayurved College, Nandi hills Dhamangaon Igatpuri Nashik
Nashik
MAHARASHTRA
422403
India |
| Phone |
8793655354 |
| Fax |
|
| Email |
rashmikurawar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Panchakarma , SMBT ayurved college and hospital ,Dhamangaon , Igatpuri , Nashik, 422403 |
|
|
Primary Sponsor
|
| Name |
Kaustubh Muley |
| Address |
OPD 19, SMBT Ayurved College, Nandi hills Dhamangaon Igatpuri Nashik Maharashtra India 422403 |
| 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 |
| Dr Rashmi Kurawar |
SMBT AYURVED COLLEGE AND HOSPITAL |
OPD no. 19 , Department of Panchakarma , SMBT Ayurved college and Hospital , Dhamangaon , Igatpuri, Nashik , 422403
Nashik
MAHARASHTRA |
9834310443
rashmikurawar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMBT Ayurved College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M543||Sciatica. Ayurveda Condition: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | mAtrAbastiH, मात्राबस्तिः | (Procedure Reference: CHARAK SAMHITA CHIKITSA STHAN 28TH ADHYAY SHLOKA 108, Procedure details: Sahachar Tail Matra Basti 60ml with core muscle strengthening excercises for 30 mins once a day )
| | 2 | Comparator Arm (Non Ayurveda) | | - | Core Muscle Strengthening Excercises | 1)Prone Bridge
2)Alternate arm and leg raise from quadruped
3)Straight leg raise from prone
4)Supine extension bridge
5)Side Bridge
6)Abdominal hollowing
Each of the excerise will be repeated 10 times with 3 sec of interval and performed once a day for nine days under expert therapist |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients with SLR Test positive at 35 degree to 75 degree.
2)Patients with classical features of Gridhrasi i.e radiating
Ruka, Toda , Stambha , in Kati, Uru, janu, Jangha, Pada direction |
|
| ExclusionCriteria |
| Details |
1) Pregnant Women
2) Neoplastic/ Traumatic/ Infective condition of spine
3) Infected joint disorder
4) Laminectomy Patient
5) Recent trauma / recent spine surgery
6) Patient not fit for Anuvasan Basti |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the efficacy of sahachar tail matra basti with core muscle strengthening excercise in gridhrasi with special reference to sciatica |
9 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study where the trial group stands in compare to control drug at the end of study |
18 months |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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 |
|
Date of First Enrollment (India)
|
02/06/2025 |
| 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 Yet Recruiting |
| 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
|
In todays fast life style people are not able to look after their health. So due to heavy work and fast life people suffer from many diseases which affect their day to day life.
Sciatica is one such disease which affects the working population and most of the economically backward heavy working population
This research helps to see the combine result of Ayurvedic treatment and Physiotherapy excercise
This gives patient a economically affordable choice of treatment.
Study Design | Subject | Group A | Group B | | Type | Trial | Control | | Drug | Sahachar Tail Matra Basti with Core Muscle Strengthening excercises | Core Muscle Strengthening excercises | | Dose | 60ml Matra Basti + 30 mins excercise once in a day in morning | 30 mins excercise once in a day in morning | | Study Observation | 9 Days | 9 Days | | Observation during treatment | Baseline 0th day , 9th day , 14th day | Baseline 0th day , 9th day , 14th day | | Route of administration | Anal and Manual excercise | Manual Excercise | | After Treatment follow up | 14th day | 14th day |
|