| CTRI Number |
CTRI/2025/04/085518 [Registered on: 24/04/2025] Trial Registered Prospectively |
| Last Modified On: |
23/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To examine the effect of matra basti with 60ml Ketkyadi Tail application in 30 participants (both male and female) of age group between 20 to 60 years with sign of sciatica. |
|
Scientific Title of Study
|
Randomised clinical study to evaluate the efficacy of Matra basti with Ketkyadi Tail in the management of grudhrasi 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 |
Hitakshi Sanjay Dhale |
| Designation |
BAMS PG Scholer (Panchakarma) |
| Affiliation |
LKR Ayurvedic college and research centre |
| Address |
Panchakarma Department, ground floor,room number 3,LKR hospital P2 MIDC area Shendri Mall, Gadhinglaj, Kolhapur 416502
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9689462032 |
| Fax |
|
| Email |
hitakshidhale@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Namrata Shirsat |
| Designation |
BAMS MD PANCHAKARMA |
| Affiliation |
LKR Ayurvedic college and research centre |
| Address |
Panchakarma Department, ground floor, room number 3, LKR hospital P2 MIDC area Shendri Mall Gadhinglaj, Kolhapur 416502
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
7798861414 |
| Fax |
|
| Email |
namishirsat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Hitakshi Sanjay Dhale |
| Designation |
BAMS PG Scholer Panchakarma |
| Affiliation |
LKR Ayurvedic college and research centre |
| Address |
Panchakarma Department, ground floor, room number 3, LKR hospital P2 MIDC area Shendri Mall, Gadhinglaj, Kolhapur 416502
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9689462032 |
| Fax |
|
| Email |
hitakshidhale@gmail.com |
|
|
Source of Monetary or Material Support
|
| Late Kedari Redekar Ayurvedic college and Research centre Tal- Gadhinglaj Dist- Kolhapur State- Maharashtra Country- India, Pin code- 416502 |
|
|
Primary Sponsor
|
| Name |
Dr. Hitakshi Sanjay Dhale |
| Address |
Laxmi nagar near lahari baba temple, Amravati Dist-Amravati State- Maharashtra Country- India, Pin code- 444604 |
| 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 Hitakshi Sanjay Dhale |
LKR Ayurvedic college and Research centre Gadhinglaj |
Panchakarma Department ground floor, room number 3, LKR hospital P2 MIDC area Shendri Mall Gadhinglaj Kolhapur 416502
Kolhapur
MAHARASHTRA |
9689462032
hitakshidhale@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| LKR Ayurvedic college and research centre Gadhinglaj |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G570||Lesion of sciatic nerve. Ayurveda Condition: GRUDHRASI (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Ketkyadi Tail , Reference: Ashtang sangrah Chikitsasthan 23/39, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -Matra basti given for continue 7 days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting sign and symptoms of Grudhrasi like ruk, toda, sthambha, Spandan in sphik, kati, prushtha, uru, janu, jangha and pada with positive SLR. |
|
| ExclusionCriteria |
| Details |
Spinal TB, Spinal deformity, Spinal tumours, severe traumatic injury, carcinoma of spine, surgical indication, congenital abnormalities in spine, Hemorrhoids and fissure in ano. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy of Matra basti with Ketkyadi Tail in grudhrasi |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study Ketkyadi Tail
To study Grudhrasi |
7 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
05/05/2025 |
| 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 study is randomised clinical study to evaluate the efficacy of Matra basti with Ketkyadi Tail in the management of Grudhrasi with special reference to Sciatica. Total 30 patients of age 20 to 60 of both sex will be selected and Ketkyadi Tail Matra basti is given for 7 days. Data will be analysed and appropriate statistical test will be applied , result will be presented. |