| CTRI Number |
CTRI/2025/05/087051 [Registered on: 16/05/2025] Trial Registered Prospectively |
| Last Modified On: |
07/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
“A Clinical study on the effect of Mahamasha Tail & Tila Taila MatraBasti in the management of Sciatica” |
|
Scientific Title of Study
|
A comparative Clinical study on the effect of Mahamasha Taila & Tila Taila
Matra Basti in the management of Gradhrasi W.S.R. 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 |
Dr Satram Kumawat |
| Designation |
P.G. Scholar |
| Affiliation |
Rani Dullaiya Smriti Ayurved Pg Mahavidyalaya Evam Chikitsalaya Bhopal |
| Address |
P.G.Department of Panchakarma,Opd no.5 ,Rani Dullaiya Smriti Ayurved Pg Mahavidyalaya Evam Chikitsalaya Barkhedi-Kalan, Bhadbhada Road Bhopal (M.P.)
Bhopal
Madhya Pradesh
462044
India
Bhopal
MADHYA PRADESH
462044
India |
| Phone |
9479471616 |
| Fax |
|
| Email |
acharyasatram@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Atul Pawar |
| Designation |
Professor Department of Panchakarma |
| Affiliation |
Rani Dullaiya Smriti Ayurved Pg Mahavidyalaya Evam Chikitsalaya Bhopal (M.P.) |
| Address |
P.G.Department of Panchakarma,Opd no.5 ,Rani Dullaiya Smriti Ayurved Pg Mahavidyalaya Evam Chikitsalaya Barkhedi-Kalan, Bhadbhada Road Bhopal (M.P.)
Bhopal
Madhya Pradesh
462044
India
Bhopal
MADHYA PRADESH
462044
India |
| Phone |
9552667702 |
| Fax |
|
| Email |
atul84pawar.ap.ap@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Atul Pawar |
| Designation |
Professor Department of Panchakarma |
| Affiliation |
Rani Dullaiya Smriti Ayurved Pg Mahavidyalaya Evam Chikitsalaya Bhopal (M.P.) |
| Address |
P.G.Department of Panchakarma,Opd no.5 ,Rani Dullaiya Smriti Ayurved Pg Mahavidyalaya Evam Chikitsalaya Barkhedi-Kalan, Bhadbhada Road Bhopal (M.P.)
Bhopal
Madhya Pradesh
462044
India
Bhopal
MADHYA PRADESH
462044
India |
| Phone |
9552667702 |
| Fax |
|
| Email |
atul84pawar.ap.ap@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rani Dullaiya Smriti Ayurved Pg Mahavidyalaya Evam Chikitsalaya Bhopal (M.P.) |
|
|
Primary Sponsor
|
| Name |
Dr. Satram Kumawat |
| Address |
P.G. Scholar,Rani Dullaiya Smriti Ayurved Pg Mahavidyalaya Evam Chikitsalaya Barkhedi-Kalan, Bhadbhada Road Bhopal (M.P.) |
| 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 Satram Kumawat |
Rani Dullaiya Smriti Ayurved Pg Mahavidyalaya Evam Chikitsalaya Bhopal (M.P.) |
Department of Panchaarma,Opd no.5, Rani Dullaiya Smriti Ayurved Pg Mahavidyalaya Evam Chikitsalaya Barkhedi-Kalan, Bhadbhada Road Bhopal (M.P.)
Bhopal
MADHYA PRADESH |
9479471616
acharyasatram@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee,Rani Dullaiya Smriti Ayurved Pg Mahavidyalaya Evam Chikitsalaya Bhopal (M.P.) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G55||Nerve root and plexus compressionsin diseases classified elsewhere. Ayurveda Condition: VYANAVATAKOPAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Mahamasha taila, Reference: chakradatta pg no. 148, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 16 Days, anupAna/sahapAna: No, Additional Information: mahamasha taila matra basti will be given | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Tila taila, Reference: Charak su. 13/12-15, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 16 Days, anupAna/sahapAna: No, Additional Information: tila taila matra basti will be given |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients have the classical signs & symptoms ofGradhrasi
2.Patients will be selected irrespective of caste and religion,gender,habitat,occupation and
socio-economic status. |
|
| ExclusionCriteria |
| Details |
1. Patients having the age below 20years & above 60 years.
2. Patients with disease like - Urahkshata, Garbhini, Ano rectal disease, Any acute disease,
Any infective disease.
3.Patient contraindicated for ‘ Basti karma ’.
4. Patient having carcinoma of spine . |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduce the pain and stiffness in lower back |
23 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduce the pain and stiffness in lower back
improvement in pricking pain and twitching |
30 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
21/05/2025 |
| 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="0"
Months="8"
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
|
Sciatica is a relatively common muscoskeletal disorder between 10% to 40% and an annual incidence of 1 to 5 % in india .One of the most prevalent Vata illnesses, GradhrasiIs characterised by pain or discomfort Connected to the sciatic nerve & is quite similar to sciatica. In the working population the prevalence of sciatica is 3.8% while it is 7.9% in the non-working population. In Ayurvedic texts , various medication and Panchkarma therapy are explained for the condition of Gradhrasi . Mahamashatailamatrabasti is indicated in vatavyadhi by bhavaprakasha in vatavyadhichikitsa. Therefore , it is selected for clinical research in the management of Gradhrasi. |