| CTRI Number |
CTRI/2025/04/084978 [Registered on: 16/04/2025] Trial Registered Prospectively |
| Last Modified On: |
20/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effective Treatment of Gridhrasi using Cupping therapy |
|
Scientific Title of Study
|
A RANDOMIZED COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF CUPPING THERAPY OVER SIRAVYADHA IN THE MANAGEMENT OF 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 |
Dr Arbina Alnaseer Mirza |
| Designation |
PG SCHOLAR |
| Affiliation |
BLDEAs AVS Ayurveda Mahavidyalaya Vijayapura |
| Address |
2nd yr PG Scholar BLDEAs AVS Ayurveda Mahavidyalaya Bagalkot Road Vijayapura Karnataka 586109 India
Department of Shalya Tantra OPD no 3 Bagalkot Road Vidya Nagar Murankeri Vijayapura Karnataka 586109
Bijapur
KARNATAKA
586109
India |
| Phone |
8669105045 |
| Fax |
|
| Email |
arbinamirza307@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aneesur Rehman M Madni |
| Designation |
Associate Professor |
| Affiliation |
BLDEAs AVS Ayurveda Mahavidyalaya Vijayapura |
| Address |
Department of Shalya tantra OPD no 3 Bagalkot Road Vijayapura Karnataka 586109
Department of Shalya tantra OPD no 3 Bagalkot Road Vidya Nagar Murankeri Vijayapura Karnataka 586109
Bijapur
KARNATAKA
586109
India |
| Phone |
9538140448 |
| Fax |
|
| Email |
anees8804@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arbina Alnaseer Mirza |
| Designation |
PG Scholar |
| Affiliation |
BLDEAs AVS Ayurveda Mahavidyalaya Vijayapura |
| Address |
2nd Yr PG Scholar BLDEAs AVS Ayurveda Mahavidyalaya Bagalkot Road Vijayapura Karnataka 586109
Department of Shalya Tantra OPD no 3 Bagalkot Road Vijayapura Karnataka 586109
Bijapur
KARNATAKA
586109
India |
| Phone |
8669105045 |
| Fax |
|
| Email |
arbinamirza307@gmail.com |
|
|
Source of Monetary or Material Support
|
| BLDEAs AVS AYURVEDA MAHAVIDYALAYA
HOSPITAL AND RESEARCH CENTRE VIJAYAPURA
586109 KARNATAKA. |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Arbina Mirza |
BLDEA AVS Ayurveda Mahavidyalaya Hospital and research centre Vijayapur. |
Room number 3 OPD Dept of Shalyatantra
Bijapur
KARNATAKA |
8669105045
arbinamirza307@gmail.com |
| Dr Arbina Alnaseer Mirza |
BLDEAs AVS AYURVEDA MAHAVIDYALAYA HOSPITAL AND RESEARCH CENTRE VIJAYAPURA |
Department of Shalyatantra OPD no 3
Bijapur
KARNATAKA |
8669105045
arbinamirza307@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee BLDEAs AVS AYURVEDA MAHAVIDYALAYA HOSPITAL AND RESEARCH CENTRE VIJAYAPURA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M468||Other specified inflammatory spondylopathies. Ayurveda Condition: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | cupping therapy | (Procedure Reference: Neethi Raveendran Surabhi Krishnan Sanath Kumar D G AYURVEDIC MANAGEMENT OF GRIDHRASI WSR TO SCIATICA WITH MODIFIED CUPPING THERAPY A CASE STUDY Published Online November 2023, Procedure details: Dry cupping will be done at the selected sites for about 3 mins
Then with help of surgical blade Prachhan karma will be done over the areas & again
cupping will be done until blood stops on its own)
|
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Positive SLR Test and patients diagnosed with gridhrasi |
|
| ExclusionCriteria |
| Details |
Vascular diseases of lower extremities and other neurological disorders of spine
Uncontrolled diabetes mellitus hypertension and other systemic diseases
Pregnancy Pain Secondary to pelvic pathologies
Contraindicated conditions of Siravyadha and Prachhana Karma
Patients with HIV HbsAg HCV |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in Sciatic nerve pain |
46 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in pain radiating from hip |
46 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
27/04/2025 |
| 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="2"
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
|
This study is A randomized comparative clinical study to evaluate the efficacy of Cupping
therapy over Siravyadha in the management of Gridhrasi with special reference to Sciatica will be conducted in BLDEAs AVS Ayurveda Mahavidyalaya, Hospital and Research Centre Vijayapura 586109 Karnataka India |