| CTRI Number |
CTRI/2025/11/096832 [Registered on: 03/11/2025] Trial Registered Prospectively |
| Last Modified On: |
01/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
MANAGEMENT OF GRIDHRASI THROUGH SHEPHALIKA PATRA KASHAYAM AND RASNA GUGGULU |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF BHAVAPRAKASHOKTA SHEPHALIKA PATRA KASHAYAM AND RASNA GUGGULU IN 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 Jitendra Patel |
| Designation |
MD Scholer |
| Affiliation |
Govt ayurveda college nipaniya rewa mp |
| Address |
Dept of Samhita Siddhant Govt ayurveda college nipaniya
rewa mp
Rewa
MADHYA PRADESH
486001
India
Rewa
MADHYA PRADESH
486001
India |
| Phone |
9340057849 |
| Fax |
|
| Email |
jitu.patel7062@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jitendra Patel |
| Designation |
MD Scholer |
| Affiliation |
Govt ayurveda college nipaniya rewa mp |
| Address |
Dept of Samhita Siddhant Govt ayurveda college nipaniya
rewa mp
Rewa
MADHYA PRADESH
486001
India
MADHYA PRADESH
486001
India |
| Phone |
9340057849 |
| Fax |
|
| Email |
jitu.patel7062@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pravanjan Acharya |
| Designation |
professor and HOD |
| Affiliation |
Govt ayurveda college nipaniya rewa mp |
| Address |
Dept of Samhita Siddhant Govt ayurveda college nipaniya
rewa mp
Rewa
MADHYA PRADESH
Rewa
MADHYA PRADESH
486001
India |
| Phone |
9827459956 |
| Fax |
|
| Email |
dr.pravanjan@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Govt ayurveda college nipaniya rewa mp |
| Address |
Dept of Samhita Siddhant Govt ayurveda college nipaniya
rewa mp
Rewa
MADHYA PRADESH
486001
India |
| 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 Jitendra Patel |
Govt ayurveda college nipaniya rewa mp |
Dept of Samhita Siddhant Govt ayurveda college nipaniya
rewa mp
Rewa
MADHYA PRADESH
486001
Rewa
MADHYA PRADESH |
9340057849
jitu.patel7062@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G579||Unspecified mononeuropathy of lower limb. Ayurveda Condition: GRUDHRASI (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shephalika patra kashayam, Reference: Bhavaprakasha Madhyama Khanda 142, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Anuushana jal), Additional Information: Nil |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients aged between 16 to 70 years of any gender
2.Patients having clinical signs and symptoms of Gridhrasi
3.Patients willing to sign the informed consent form
4. SLR (Straitght Leg Raising) Test positive |
|
| ExclusionCriteria |
| Details |
1. Pregnancy & Lactating women
2. Tuberculosis of spine
3. Diabetes mellitus
4. Cardiac Disease
5. Congenital Disease
6. Traumatic injury |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| improvement in subjective parameters like Ruk Stambh Tod Muhuspandana Graha Aruchi Tandra Gaurava |
on 0 days to 30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improvement in subjective parameters like Ruk Stambh Tod Muhuspandana Graha Aruchi |
on 0 days to 30 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 3 |
|
Date of First Enrollment (India)
|
30/04/2026 |
| 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
|
The present clinical study entitled A Comparative Clinical Study to Evaluate the Efficacy of Bhavaprakashokta Shephalika Patra Kashayam and Rasna Guggulu in Gridhrasi w.s.r. to Sciatica aims to evaluate and compare the therapeutic effects of two classical Ayurvedic formulations in the management of Gridhrasi, a Vatavyadhi closely correlated with sciatica.
Gridhrasi is characterized by Ruka Stambha Toda Muhuspandana and Sakthikshepa Nigraha often accompanied by Tandra, Gaurava, and Arochaka in Kaphanubandha type. The condition corresponds to the modern entity “sciatica,” involving radiating pain along the sciatic nerve due to compression or irritation.
The study is designed as a prospective, open-labelled, randomized clinical trial conducted on 40 patients, divided into two groups of 20 each. Group A Shephalika Patra Kashayam 50 ml twice daily before meals Group B Rasna Guggulu 250 mg twice daily after meals The treatment duration is 30 days, with a follow-up of 15 days, and both groups receive Ushna Jala as Anupana.
Both formulations are selected for their Vata-Kapha Shamak, Vedanasthapana, Amapachaka, and Shothahara properties. Shephalika Patra Kashayam Vitex negundo Linn. possesses Ushna Veerya and Katu Vipaka, aiding in pain and inflammation reduction and Amapachana. Rasna Guggulu combines Rasna Pluchea lanceolata and Guggulu Commiphora mukul providing potent Vatashamaka, anti-inflammatory, and analgesic actions.
This study seeks to establish a comparative evaluation of these two Ayurvedic regimens to determine which provides better relief in terms of pain, stiffness, and functional improvement, thereby offering an effective, safe, and economical alternative for the management of Gridhrasi |