| CTRI Number |
CTRI/2025/04/084000 [Registered on: 03/04/2025] Trial Registered Prospectively |
| Last Modified On: |
02/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study to evaluate efficacy of Vishwadidwadashanga kashaya in Gridhrasi w.r.t Sciatic Radiculopathy |
|
Scientific Title of Study
|
A SIMPLE RANDOMISED CONTROLLED CLINICAL STUDY TO EVALUATE
THE EFFICACY OF VISHWADIDWADASHANGA KWATHA IN GRIDHRASI VIS-A-VIS SCIATIC RADICULOPATHY |
| 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 Apoorva KS |
| Designation |
PG Scholar |
| Affiliation |
Sushrutha Ayurvedic Medical College and Hospital |
| Address |
Room No 5, Department of Kayachikitsa, Department of PG studies,
Sushrutha Ayurvedic Medical College and Hospital Prashanthi
Kuteera, Jodi Bingipura, Jigani, Anekal Taluk
Bangalore
KARNATAKA
560105
India |
| Phone |
7899063585 |
| Fax |
|
| Email |
apoorvaks2412@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SOWMYA.S.B |
| Designation |
Professor |
| Affiliation |
Sushrutha Ayurvedic Medical College and Hospital |
| Address |
Room No 5, Department of Kayachikitsa, Department of PG studies,
Sushrutha Ayurvedic Medical College and Hospital Prashanthi
Kuteera, Jodi Bingipura, Jigani, Anekal Taluk
Room No 5, Department of Kayachikitsa, Department of PG studies,
Sushrutha Ayurvedic Medical College and Hospital Prashanthi
Kuteera, Jodi Bingipura, Jigani, Anekal Taluk
Bangalore
KARNATAKA
560105
India |
| Phone |
9916149850 |
| Fax |
|
| Email |
drsbsowmya.ayu@gmaol.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Apoorva KS |
| Designation |
PG Scholar |
| Affiliation |
Sushrutha Ayurvedic Medical College and Hospital |
| Address |
Room No 5, Department of Kayachikitsa, Department of PG studies,
Sushrutha Ayurvedic Medical College and Hospital Prashanthi
Kuteera, Jodi Bingipura, Jigani, Anekal Taluk
Bangalore
KARNATAKA
560105
India |
| Phone |
7899063585 |
| Fax |
|
| Email |
apoorvaks2412@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Kayachikitsa, Department of PG studies Division, Sushrutha Ayurvedic Medical
College and Hospital, Prashanthi Kuteera, Jodi Bingipura, Jigani, Anekal Taluk, Bengaluru,
Karnataka, India - 560105 |
|
|
Primary Sponsor
|
| Name |
Dr Apoorva KS |
| Address |
Room No 5, Department of Kayachikitsa, Department of PG studies Division, Sushrutha Ayurvedic Medical College and Hospital, Prashanthi Kuteera, Jodi Bingipura, Jigani, Anekal Taluk
Bengaluru, Karnataka,India - 560105 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Sushrutha Ayurvedic Medical College and Hospital |
Prashanthi Kuteera, Jodi Bingipura, Jigani,
Anekal Taluk, Bengaluru - 560105 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Apoorva KS |
Sushrutha Ayurvedic Medical College and Hospital |
Room No 4,
Department of
Kayachikitsa, Out
Patient Department,
Prashanthi Kuteera,
Jodi Bingipura, Jigani,
Anekal Taluk
Bangalore
KARNATAKA |
7899063585
apoorvaks2412@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, SAMC & H |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M958||Other specified acquired deformities of musculoskeletal system. Ayurveda Condition: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vishwadidwadashanga Kashaya, Reference: Gada Nighraha, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 12(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 10 Days, anupAna/sahapAna: Yes(details: Water), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Bhrihat Panchamoola Kashaya, Reference: Bhavamishra, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 12(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 10 Days, anupAna/sahapAna: Yes(details: warm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
• Subjects of age group between 19-60yrs of both genders who fit into diagnostic criteria of Gridhrasi.
• Subjects who are not under any medication, and subjects who have completed the washout period of the previous medications including corticosteroids prior to the day 1 of clinical study.
• Subjects who give consent for the clinical study.
|
|
| ExclusionCriteria |
| Details |
Subjects with H/O Neoplastic condition of Spine, Spine infections like T.B, Recent H/O spinal fractures.
Pregnant and Lactating women.
|
|
|
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
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in the symptoms of Sciatic Rdiculopathy is
assessed using
Straight leg raise test (SLRT)
VAS
Lumbar spine mobility Test (Gibe’s test)
Oswestry Disability index Questionnaire
Clinical features of Gridhrasi
|
Reduction in the symptoms of Sciatic Rdiculopathy is
assessed using
Straight leg raise test (SLRT)
VAS
Lumbar spine mobility Test (Gibe’s test)
Oswestry Disability index Questionnaire
Clinical features of Gridhrasi
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in the symptoms of Sciatic Rdiculopathy is
assessed using
Straight leg raise test (SLRT)
VAS
Lumbar spine mobility Test (Gibe’s test)
Oswestry Disability index Questionnaire
Clinical features of Gridhrasi
|
1st & 11th day |
|
|
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)
|
20/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/04/2025 |
| 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 simple randomized, comparative clinical trial to evaluate the efficacy of Vishwadidwadashanga kashaya, 12ml twice a day, in Group A with minimum of 20 subjects, Bhrihatpanchamoola kashaya of 12ml twice a day, in Group B with minimum of 20 subjects in management of Gridhrasi vis-a-vis Sciatic Radiculopathy for a period of 10days. The primary outcome is to reduce the pain and secondary outcome is to improve quality of life. |