| CTRI Number |
CTRI/2025/10/096199 [Registered on: 21/10/2025] Trial Registered Prospectively |
| Last Modified On: |
15/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to evaluate the effect of an Ayurvedic formulation containing castor oil (Eranda taila) and Haritaki powder in relieving symptoms of Sciatica (Gridhrasi). |
|
Scientific Title of Study
|
Single arm clinical study to evaluate the role of Eranda taila yukta Haritaki churna as a upashayatmaka role 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 Vaibhav Mohan Awatade |
| Designation |
PG Scholar |
| Affiliation |
Yashwant Ayurvedic College Post Graduate Training And Research Centre Kodoli |
| Address |
Rognidan Department Second Floor
Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli
Tal Panhala Dist Kolhapur MAHARASHTRA
416114 India
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
7057598625 |
| Fax |
|
| Email |
vaibhavawatade21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashok Sadashiv Patil |
| Designation |
HOD of Rognidan Department |
| Affiliation |
Yashwant Ayurvedic College Post Graduate Training And Research Centre Kodoli |
| Address |
Rognidan Department Second Floor
Yashwant Ayurvedic College Post Graduate Training and Research
Centre Kodoli
Tal Panhala Dist Kolhapur MAHARASHTRA
416114 India
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9423802308 |
| Fax |
|
| Email |
drashok.rognidan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vaibhav Mohan Awatade |
| Designation |
PG Scholar |
| Affiliation |
Yashwant Ayurvedic College Post Graduate Training And Research Centre Kodoli |
| Address |
Rognidan Department Second Floor
Yashwant Ayurvedic College Post Graduate Training and Research
Centre Kodoli
Tal Panhala Dist Kolhapur MAHARASHTRA
416114 India
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
7057598625 |
| Fax |
|
| Email |
vaibhavawatade21@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patients at Yashwant Ayurvedic medical college, Post graduation training and Research centre, Kodoli, Tal- Panhala, Dist- Kolhapur, Maharashtra, India 416114 |
|
|
Primary Sponsor
|
| Name |
Dr Vaibhav Mohan Awatade |
| Address |
Rognidan Department Second Floor
Yashwant Ayurvedic College Post Graduate Training and Research
Centre Kodoli
Tal Panhala Dist Kolhapur MAHARASHTRA
416114 India |
| Type of Sponsor |
Other [Self ] |
|
|
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 Vaibhav Mohan Awatade |
Yashwant Dharmarth Rugnalay, Kodoli |
Rognidan Department Second Floor
Yashwant Ayurvedic College Post Graduate Training and Research
Centre Kodoli
Tal Panhala Dist Kolhapur MAHARASHTRA
416114 India
Kolhapur
MAHARASHTRA |
7057598625
vaibhavawatade21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Yashwant Ayurvedic College PGT and RC Kodoli |
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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Eranda Taila yukta Haritaki Churna, Reference: Bhavprakash, Madhyam Khand, Adhyay 26, Shlok no. 51, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 31 Days, anupAna/sahapAna: Yes(details: -Koshna Jal), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
01. Irrespective of gender caste religion socioeconomic status
02. Patients having lakshanas of Gridhrasi ap per ayurvedic texts
03. Patients having positive slr test on examination
04. Patients with recurrence of gridhrasi |
|
| ExclusionCriteria |
| Details |
01. Known case of ischemic heart disease patients at high risk
02. Patients with immune compromised disease like leukemia hepatitis, AIDS |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the Upashayatmaka Role of Eranda taila yukta Haritaki churna in Gridhrasi |
Assessment on 0th, 8th, 16th, 24th and 31st day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
01. To study the Nidanpanchak of Gridhrasi
02. To study the literature of Sciatica
03. To reduce discomfort and complaints of patients |
Assessment on 0th, 8th, 16th, 24th and 31st day |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
27/10/2025 |
| 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="6"
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 is SINGLE ARM CLINICAL STUDY TO EVALUATE THE ROLE OF ERANDA TAILA YUKTA HARITAKI CHURNA AS A UPASHAYATMAKA ROLE IN GRIDHRASI W. S. R. TO SCIATICA This study will be done in the Rognidan department of Yashwant Ayurvedic Medical College Kodoli, Tal-Panhala, Dist-Kolhapur. This study will be carried out in single group by observing upashayatmaka effect of Eranda taila yukta Haritaki churna given 10 ml and 3 gm respectively for 31 days at Nishakala. Then result will be observed, and the conclusion will be drawn on the basis of observed values. |