| CTRI Number |
CTRI/2025/03/082355 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
07/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To Check The Efficacy Of Gridhrasinashak Kashay in The Management Of Gridhrasi(Sciatica) |
|
Scientific Title of Study
|
Single Arm Clinical Study To Evaluate The Efficacy Of Gridhrasinashak Kashay In The Management Of Gridhrasi(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 Mahantesh Mallesh Katti |
| Designation |
PG Scholar |
| Affiliation |
Bharati vidyapeeth (Deemed to be university) College of ayurved pune |
| Address |
Bharati vidyapeeth (Deemed to be university) College of Ayurveda Kayachikitsa department OPD no 4 Katraj-Dhankawadi pune
Pune
MAHARASHTRA
411043
India |
| Phone |
7083538720 |
| Fax |
|
| Email |
mahantesh.katti-ayurved@bvp.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dattatray Shinde |
| Designation |
Professor and HOD |
| Affiliation |
Bharati vidyapeeth (Deemed to be university)college of ayurved pune |
| Address |
Bharati vidyapeeth (Deemed to be university) College of Ayurveda Kayachikitsa department OPD no 4 Katraj-Dhankawadi pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9890111954 |
| Fax |
|
| Email |
dattatray.shinde@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dattatray Shinde |
| Designation |
Professor and HOD |
| Affiliation |
Bharati vidyapeeth (Deemed to be university)college of ayurved pune |
| Address |
Bharati vidyapeeth (Deemed to be university) College of Ayurveda Kayachikitsa department OPD no 4 Katraj-Dhankawadi pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9890111954 |
| Fax |
|
| Email |
dattatray.shinde@bharatividyapeeth.edu |
|
|
Source of Monetary or Material Support
|
| Bharati vidyapeeth college of ayurveda and hospital Dhankawadi- Katraj pune 411043 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Dr Mahantesh Katti |
| Address |
Bharati vidyapeeth Deemed to be university College of ayurveda and Hospital Dhankawadi- Katraj pune 411043 Maharashtra 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 Mahanesh Katti |
Bharti Vidyapeeth Deemed to be University College of Ayurved and Hospital Pune Satara Road 411043 |
Department Of Kayachikitsa Second Floor Passage Area Room Name- Head Of The Department Dr. Dattatraya L. Shinde M.D PhD Professor Dept. Of Kayachikitsa Pune Maharashtra
Pune
MAHARASHTRA |
7083538720
mahanteshkatti008@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE BVDUCOA EC |
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: GRIDHRASINASHAK KASHAY, Reference: 10. Bhaisajya Ratnavali of Govind Dasji Bhaisagratna Commented upon by Vaidya Shri Ambika Datta Shastri,English Transisation by Dr. Kanjiv Lochan ,Vatvyadhi Adhyay Shlock no 39, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with presence of Ruk(pain), Toda (Pricking Pain), Stambha (Stifiness), and Spandan (Twitching) in the Spik, Prushta(Lower back), Kati(waist), Uru(thigh), Janu(knee), Jangha(calf) and Pada(feets) |
|
| ExclusionCriteria |
| Details |
Patients suffering from several traumatic injury,spinal tumor and spinal deformity .
Patients of Gridhrasi associated with any of following disorder will be excluded from study such as Rheumatoid arthritis,Auto immune disease.
Any other inflammatory disorder like Tubercular Arthritis, Septic Arthritis, Tuberculosis of spine.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in SLR Test
Improvement in Walking time.
|
baseline,7th,14th,21th,28th,35th
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction in signs and symptoms of Gridhrasi
Improvement in VAS scale.
|
baseline,7th,14th,21th,28th,35th
|
|
|
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)
|
18/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
18/03/2025 |
| 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
|
The study will conducted after obtaining permission from institutional ethical community & will beregistered CTRI India. As per inclusion criteria patient will be selected & screening done at OPD. Subjective & Objective parameters will be checked & noted. Whole research procedure & Aim will be clearly informed to patients hence Form will be signed byenrolled participants & case report form will be filled. |