| CTRI Number |
CTRI/2025/11/097171 [Registered on: 11/11/2025] Trial Registered Prospectively |
| Last Modified On: |
07/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to evaluate the effectiveness of garlic milk and Sahacharadi Kashayam followed by Agnikarma in patients with sciatica (Gridhrasi).” |
|
Scientific Title of Study
|
A comparative study to evaluate the efficacy of Lashuna Ksheerapaka and Sahacharadi Kashayam followed by Agnikarma in the management of Vata Kaphaja Gridhrasi.
|
| 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 Mayank pratap singh |
| Designation |
Pg scholar |
| Affiliation |
Shree shivyogeeshwar rural ayurvedic medical college & Hospital |
| Address |
Shree Shivayogeeshwar rural Ayurvedic Medical College & Hospital, Ichal, Belgavi.
Shree Shivayogeeshwar Rural Ayurvedic Medical College & Hospital, Inchal, Belgavi-591102
Belgaum
KARNATAKA
591102
India |
| Phone |
7757998017 |
| Fax |
|
| Email |
mayankpratapsingh122@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr RC yakkundi |
| Designation |
Professor head of department |
| Affiliation |
Shree shivyogeeshwar rural ayurvedic medical college & Hospital |
| Address |
Shree Shivayogeeshwar Rural Ayurvedic Medical College & Hospital,Inchal, Belgavi.
Shree Shivayogeeshwar Rural Ayurvedic Medical College & Hospital, Inchal, Belgavi-591102
Belgaum
KARNATAKA
591102
India |
| Phone |
9986265349 |
| Fax |
|
| Email |
ryakkundi298@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mayank pratap singh |
| Designation |
Postgraduate scholar, department of Shalyatantra |
| Affiliation |
Shree shivayogeeshwar rural ayurvedic medical college & hospital. |
| Address |
Shree Shivayogeeshwar Rural Ayurvedic Medical College & Hospital, Inchal, Belgavi.
Shree Shivayogeeshwar Rural Ayurvedic Medical College & Hospital, Inchal, Belgavi-591102
Belgaum
KARNATAKA
591102
India |
| Phone |
7757998017 |
| Fax |
|
| Email |
mayankpratapsingh122@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Shivayogeeshwar Rural Ayurvedic Medical College & Hospital |
|
|
Primary Sponsor
|
| Name |
Shri Shivayogeeshwar Rural Ayurvedic Medical College Hospital |
| Address |
Shri Shivayogeeshwar Rural Ayurvedic Medical College & Hospital, Inchal, Belgavi, Karnataka-591102 |
| Type of Sponsor |
Private 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 RC yakkundi |
Shri Shivayogeeshwar Rural Ayurvedic Medical College and Hospital |
Shree Shivayogeeshwar Rural Ayurvedic Medical College and Hospital, Inchal, Karnataka-591102, Belgaum Karnataka
Belgaum
KARNATAKA |
9986265349
ryakkundi298@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M544||Lumbago with sciatica. Ayurveda Condition: Gri, (2) ICD-10 Condition:M543||Sciatica. Ayurveda Condition: Gridh, (3) ICD-10 Condition:M543||Sciatica. Ayurveda Condition: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Sahacharadi kashaya, Reference: Sahasrayoga kashaya prakaran , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: Ushna jala), Additional Information: This group is dealt with sahacharadi kashayam followed by Agnikarma | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Lashuna ksheerpaka , Reference: Ch.chi 28/137-138, Route: Oral, Dosage Form: Ksheerpaka, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: Warm water), Additional Information: Group 1 is dealt with administration of lashuna ksheerpaka followed by Agnikarma. | | 3 | Comparator Arm | Procedure | - | agnikarma, अग्निकर्म | (Procedure Reference: Su.su 12/10-11, Procedure details: Agnikarma is a therapeutic cauterization procedure where a red-hot metallic rod is briefly applied to specific dermatones (pain point) along the sciatic nerve pathway to relieve pain, stiffness, and other Vata symptoms in Gridhrasi, and done once in week.)
(1) Medicine Name: Lashuna ksheerpaka , Reference: Ch.chi 28/137-138, Route: Oral, Dosage Form: Ksheerpaka, Dose: 48(ml), Frequency: bd, Duration: 28 Days |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria:
1. Age group between 16 to 70 years in both sexes.
2. Presence of clinical features of Gridhrasi i.e Ruk, Toda, Spandana, and Stambha.
3. Pain along the course of Sciatica nerve.
4. Patient fit for Ausadhpana and Agnikarma procedure.
5. Straight Leg Raising (SLR) test being positive. |
|
| ExclusionCriteria |
| Details |
Patient with systemic disease like uncontrolled diabetes, hypertension, tuberculosis, HIV, HBSAg etc. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in pain, stiffness, numbness in foot, gait improvement . |
Duration-28 days
Interventional period -15 days
Follow-up after 21st and 28th days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluation of efficacy of lashuna ksheerpaka and sahacharadi kashayam followed by agnikarma in management of Vata kaphaj gridhrasi. |
Total duration- 28 days
Interventional- 15 days
Follow-up at 21st and 28th 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 1 |
|
Date of First Enrollment (India)
|
25/11/2025 |
| 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 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
|
This study compare the effectiveness of lashuna ksheerpaka over sahachardi kashayam followed by Agnikarma respectively in the management of Vata kaphaj Gridhrasi. 40 patient will be randomly divided into two group. One group receive lashuna ksheerpaka followed by agnikarma Another group receive sahacharadi kashayam followed by agnikarma Total study duration -28 days Interventional duration-14 days Follow up on 21st and 28th days The study aims to evaluate the efficacy of lashuna ksheerpaka and sahacharadi kashayam followed by Agnikarma in management of Vata kaphaj gridhrasi. |