| CTRI Number |
CTRI/2025/04/085847 [Registered on: 28/04/2025] Trial Registered Prospectively |
| Last Modified On: |
11/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Matra Basti and Kati Basti with Ashtakatwara Taila in Sciatica Ayurvedic Management |
|
Scientific Title of Study
|
RANDOMIZED COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFECT OF MATRA BASTI AND KATI BASTI WITH ASHTAKATWARA TAILA IN THE MANAGEMENT OF GRIDHRASI 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 Rampal |
| Designation |
PG Scholar |
| Affiliation |
Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan |
| Address |
PG Scholar
PG Department of Panchkarma
Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
9214677717 |
| Fax |
|
| Email |
rpjat06@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajeev Kumar Pandey |
| Designation |
Associate Professor |
| Affiliation |
Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan |
| Address |
Associate Professor
PG Department of Panchkarma
Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
9461234378 |
| Fax |
|
| Email |
rajeevpanchakarma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajeev Kumar Pandey |
| Designation |
Associate Professor |
| Affiliation |
Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan |
| Address |
Associate Professor
PG Department of Panchkarma
Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
9461234378 |
| Fax |
|
| Email |
rajeevpanchakarma@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Madan Mohan Malviya Government Ayurved College Udaipur |
| Address |
Rada ji circle Ambamata Scheme Udaipur Rajasthan India
PIN 313001 |
| Type of Sponsor |
Government 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 |
| Dr Rampal |
Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan |
OPD NO 1 3 4
PG Department of Panchkarma
Government Ayurved Research Center Gulab Bag
Associated Group of Hospital
Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan
Udaipur
RAJASTHAN |
9214677717
rpjat06@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE M.M.M. Govt. Ayurved College Ambamata Udaipur |
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 | Comparator Arm | Procedure | - | kaTibastiH, कटिबस्तिः | (Procedure Reference: sashasryoga, Procedure details: oil pooling on lumbar region for 45 minutes)
(1) Medicine Name: ashtakatwar taila, Reference: ch.chi.27/47, Route: Topical, Dosage Form: Taila, Dose: 200(ml), Frequency: od, Duration: 15 Days | | 2 | Intervention Arm | Procedure | - | mAtrAbastiH, मात्राबस्तिः | (Procedure Reference: ch.chi.27/47, Procedure details: medicine will be inseminated by anal route by this procedure)
(1) Medicine Name: ashtakatwara taila, Reference: ch.chi.27/47, Route: Rectal, Dosage Form: Taila, Dose: 72(ml), Frequency: od, Duration: 15 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosed and confirmed cases of Gridhrasi (Sciatica).
2. Patients between the age group of 20-70 years, irrespective of religion, sex, occupation, cast etc.
3. Patients willing to give written consent.
|
|
| ExclusionCriteria |
| Details |
1. Known cases of any major illness e.g. uncontrolled HTN, DM, TB, AIDS, Malignancy, etc.
2. Patients below the age of 20 years and above 70 years
3. Patients having Wound, Stitches, Abrasions, Abscess, Bruise, Cut & other types of injury on lumber region.
4. Patients who have lost the control on bladder and defecation.
5. Pregnant women.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| reduction pain in patient suffering sciatica |
30,45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| reduction in associated symptoms in sciatica |
30,45 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)
|
30/04/2025 |
| 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="0"
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
|
Gridhrasi is an intractable physical complaint which
affects the ambulatory functiomn of the patient. Gridhrasi comes under 80 types of Nanatmaja Vatavyadhi though, occasionally there is Kaphanubandha. The name itself indicates
the gate shown by the patients due to extreme pain just like a Gridhra (vulture), it is clear that this
disease not only inflicts pain but
also causes difficulty in walking, which is very much frustrating and embracing
to the patient. The cardinal signs and symptoms of Gridhrasi are Ruka (Pain),
Toda (Pricking sensation), Stambha (Stiffness) and MuhuGridhrasi is an intractable physical complaint which
affects the ambulatory functiomn of the patient. Gridhrasi comes under 80 types of Nanatmaja Vatavyadhi though, occasionally there is Kaphanubandha. The name itself indicates
the gate shown by the patients due to extreme pain just like a Gridhra (vulture), it is clear that this
disease not only inflicts pain but
also causes difficulty in walking, which is very much frustrating and embracing
to the patient. The cardinal signs and symptoms of Gridhrasi are Ruka (Pain),
Toda (Pricking sensation), Stambha (Stiffness) and Muhuspandana (Twitching) in the Sphika, Kati, Uru, Janu, Jangha and Pada1spandana (Twitching) in the Sphika, Kati, Uru, Janu, Jangha and Pada1.Sciatica is a form of lower back pain and it is
an important clinical, and public health problem. In present scenario, the
treatment modalities for sciatica is conservative treatment with analgesic,
physiotherapy, muscle relaxants, narcotics and few require surgery which has
its own disadvantages or expensive. Previously on Gridhrasi no research work done on the comparison of Matra Basti7 and Kati Basti8 with
Ashtakatwara Taila9, so this study is being undertaken to see
the effect of Matra Basti and Kati Basti with Ashtakatwara Taila in the patient of Gridhrasi w.s.r. to Sciatica |