| CTRI Number |
CTRI/2020/12/029850 [Registered on: 16/12/2020] Trial Registered Prospectively |
| Last Modified On: |
16/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Add on efficacy and safety of Myostaal liniment for the reduction of spasticity of the muscles with only Physiotherapy given group. |
|
Scientific Title of Study
|
A prospective, randomized, comparative, parallel, 2- arm study to evaluate the efficacy and safety of a Myostaal liniment application as add on therapy for the reduction of spasticity in patients suffering from Hemiplegia. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hemant Toshikhane |
| Designation |
Professor / Dean |
| Affiliation |
Parul Institute Of Ayurveda / Parul University |
| Address |
Department of Shalya Tantra, Parul Ayurved Hospital and Parul Institute of Ayurveda; Parul University, Vadodara , Gujarat - 391760
Vadodara
GUJARAT
391760
India |
| Phone |
9964596478 |
| Fax |
|
| Email |
drhemantt@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hemant Toshikhane |
| Designation |
Professor / Dean |
| Affiliation |
Parul Institute Of Ayurveda / Parul University |
| Address |
Department of Shalya Tantra, Parul Ayurved Hospital, Parul Institute of Ayurveda; Parul University, Vadodara , Gujarat - 391760
Vadodara
GUJARAT
391760
India |
| Phone |
9964596478 |
| Fax |
|
| Email |
drhemantt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hemant Toshikhane |
| Designation |
Professor / Dean |
| Affiliation |
Parul Institute Of Ayurveda / Parul University |
| Address |
Department of Shalya Tantra, Parul Ayurved Hospital and Parul Institute of Ayurveda; Parul University, Vadodara , Gujarat - 391760
Vadodara
GUJARAT
391760
India |
| Phone |
9964596478 |
| Fax |
|
| Email |
drhemantt@gmail.com |
|
|
Source of Monetary or Material Support
|
| Solumiks Herbaceuticals Limited, 135, Nanubhai Desai Rd, Charni Road East, Khetwadi, Girgaon, Mumbai, Maharashtra 400004 |
|
|
Primary Sponsor
|
| Name |
Solumiks Herbaceuticals Limited |
| Address |
Solumiks Herbaceuticals Limited, 135, Nanubhai Desai Rd, Charni Road East, Khetwadi, Girgaon, Mumbai, Maharashtra 400004 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Superintendent |
Khemdas Ayurveda Hospital, Parul University, AP Ishwarpura, Tal Waghodia, Vadodara, Gujarat 391760 |
| Superintendent |
Parul Ayurveda Hospital, Parul University, AP Limda, Tal Waghodia, Vadodara, Gujarat 391760 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Divya B |
Khemdas Ayurveda Hospital |
OPD No 8, Khemdas
Ayurved Hospital, Parul
Institute of Ayurveda and
Research,Parul University,
P.O. Limda, Tal. Waghodia,
Vadodara 391760
Vadodara
GUJARAT
Vadodara
GUJARAT |
9844810958
dr.divyadeva3@gmail.com |
| Dr Sangeeta Toshikhane |
Parul Ayurveda Hospital |
OPD no-105, Dept.of Panchakarma Parul institute of Ayurveda; Parul University, Vadodara, Gujarat-391760
Vadodara
GUJARAT |
9964596479
drsangeetaj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Human Research |
Approved |
| PIAR - Institutional Ethics Committee for Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G819||Hemiplegia, unspecified. Ayurveda Condition: Hemiplegia - Unspecified , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Myostaal liniment application and Physiotherapy exercises over affected part of the body |
Application of Myostaal liniment once per day and standard physiotherapy exercises for 30 days |
| Comparator Agent |
Physiotherapy exercises for affected part of the body |
standard physiotherapy exercises for 30 days |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient of either sex in the age group of 30-70 years.
2. Diagnosed case of Hemiplegia who is stable after onset up to 01 year.
3. Patients willing to give written informed consent.
4. Patients willing to follow up. |
|
| ExclusionCriteria |
| Details |
Subject Exclusion Criteria:
1. Comatose patients.
2. Patient on : (a) oral multi-vitamin therapy within the previous 07 days, or (b) intramuscular multiviatmins within 07 days, or (c) Oral protein suppliments which claims to enhance the muscle power, or (d) topical corticosteroid at the site of application within 14 days; Or patient requiring systemic corticosteroids during the course of study.
(e) Patients on NSAIDS use will be excluded
3. Patient who has undergone cranial surgery or who is planning to undergo surgery in next 1 month will be excluded from the study.
4. Patients suffering from cerebral and cerebellar atrophy due to infectious diseases like encephalitis.
5. Patient with space occupying lesions and known case of Epilepsy.
6. Patients with auto-immune disease, uncontrolled hypertension,
7. Diabetes mellitus requiring insulin injections, chronic severe respiratory disease and severe active infectious disease requiring hospitalization.
8. Patient with history of any other systemic illness, life threatening cardiovascular and other progressive neurological diseases.
9. Patient with history of severe allergy or anaphylactic reaction.
10. Patient participating in another investigational drug trial in the previous 30 days.
11. Patients who cannot give valid consent such as mentally retarded, unconscious patients and psychiatric illness
12. History of HIV, Hepatitis B or any immune deficient conditions |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in muscle strength assessed on basis of “Tardieu Scale†to assess the spasticity, Goniometer to assess the Range of movement of affected shoulder joint, elbow joint and wrist joint |
at baseline, 15 days, at the end of 30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient’s Global safety assessment score |
at baseline, 15 days, 30 days |
| Adverse events recording |
at baseline, 15 days, at the end of 30 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="33" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
21/12/2020 |
| Date of Study Completion (India) |
26/11/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet Published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Stroke is the second leading cause of death amongst the persons above 60years of age, the fifth leading cause of death among 15-59 years old population and the leading cause of disability worldwide. According to WHO 15 million people suffer from stroke worldwide each year (WHO 2002). In India stroke prevalence rate 84-262/100000 in rural; 334-424/100000 in urban area. Mid cerebral artery is the most common vascular lesion in cerebro vascular accidents. In stroke when the injured area of brain controls Muscle tone, spasticity occurs. Effect of spasticity includes Stiff fingers, arm or legs affecting function of the muscles and mobility of joints. Each person of stroke requires a comprehensive rehabilitation programme to help them regain their quality of life; this involves a multidisciplinary team approach with inputs from physician, physiotherapists. Physiotherapy enables people to relearn lost abilities and regain independence. Massage therapy aims to prevent stiffness of affected limbs. |