| CTRI Number |
CTRI/2024/07/071306 [Registered on: 25/07/2024] Trial Registered Prospectively |
| Last Modified On: |
23/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the effect of ayurvedic formulation in sciatica |
|
Scientific Title of Study
|
Randomised controlled clinical trial to assess the effecacy of panchamuli kwatha in the management of gridhrasi 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 |
Dr Aishwarya ghatage |
| Designation |
Pg scholar |
| Affiliation |
LRP ayurvedic medical College and hospital pg institute and research centre islampur |
| Address |
LRP ayurvedic medical College and hospital pg institute and research centre islampur. Kayachikitsa OPD no 1
Sangli
MAHARASHTRA
415409
India |
| Phone |
7057508990 |
| Fax |
|
| Email |
aishwaryaghatage12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr sonal shah |
| Designation |
HOD and associate professor |
| Affiliation |
LRP ayurvedic medical College and hospital pg institute and research centre islampur |
| Address |
LRP ayurvedic medical College and hospital pg institute and research centre islampur kayachikitsa OPD no1
Sangli
MAHARASHTRA
415409
India |
| Phone |
917972759476 |
| Fax |
|
| Email |
drsonalshah2014@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aishwarya Ghatage |
| Designation |
Pg scholar |
| Affiliation |
LRP ayurvedic medical College and hospital pg institute and research centre islampur |
| Address |
LRP ayurvedic medical College and hospital pg institute and research centre islampur kayachikitsa OPD no 1
Sangli
MAHARASHTRA
415409
India |
| Phone |
7057508990 |
| Fax |
|
| Email |
aishwaryaghatage12@gmail.com |
|
|
Source of Monetary or Material Support
|
| LRP ayurvedic medical College and hospital pg institute and research centre islampur dist sangali 415409 |
|
|
Primary Sponsor
|
| Name |
Dr Aishwarya ghatage |
| Address |
LRP ayurvedic medical College and hospital pg institute and research centre islampur dist sangali 415409 kayachikitsa OPD no1 |
| 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 Aishwarya ghatage |
Kayachikitsa OPD LRP ayurvedic College islampur |
LRP ayurvedic medical College and hospital pg institute and research centre islampur Kayachikitsa OPD room no 1
Sangli
MAHARASHTRA |
7057508990
aishwaryaghatage12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee LRPAMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G55||Nerve root and plexus compressionsin diseases classified elsewhere. Ayurveda Condition: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Panchamuli kwatha, Reference: Bhaishjya ratnavali 39/20, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with clinical signs and symptoms of Gridhrasi will be selected. (Ruk, Thoda, Sthamba, Spandana, in the Sphik, Kati, Prushta, Uru, Janu, Janga and Pada)
2. Patients of either gender with the age group between 20-60 years will be selected.
3. Patients with Positive SLR & Slump Test will select. |
|
| ExclusionCriteria |
| Details |
Patients with the K/C/O following diseases will be excluded from the study-Spinal Deformity Spinal Tumors ,
Spinal TB ,Severe Traumatic Injury,
Viral Infection like Poliomyelitis.
Carcinoma ,Congenital abnormalities in spine.
Surgical indication. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To reduce the sign and symptoms of sciatica |
30 days study with followup of 0,15,30 th day (0,15,30days) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the effect of ayurvedic formulation in sciatica |
30 days study followup on 0,15,30th day (0,15,30 day) |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
03/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
03/08/2024 |
| 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
|
condition described in modern medicine resembles with Gridhrasi . In Sciatica there is intolerable pain throughout the distribution of Sciatica nerve which ends to the outer border of foot.
Herniation or degenerative changes in intervertibral disc is the most common causes. There are often history of trauma, as twisting of the spine, lifting heavy objects or exposure to cold. As the advancement of busy professional and social life, about 50% of working adults experience back injury every year. and improper sitting posture in offices , over exertion, jerking movements during travelling and sports - all these factors create undue pressure to the spinal cord and play an important role in producing low backache and sciatica. |