| CTRI Number |
CTRI/2024/07/070548 [Registered on: 13/07/2024] Trial Registered Prospectively |
| Last Modified On: |
11/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Dhattura Transdermal Patch in Management of Pain in Ankle Sprain. |
|
Scientific Title of Study
|
A randomized open label controlled clinical study to evaluate the efficacy of Dhattura Transdermal Patch in the management of pain due to sports injury with special reference to Ankle Sprain. |
| 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 Prithvi V |
| Designation |
PG Scholar |
| Affiliation |
Sri Sri College of Ayurvedic Science And Research |
| Address |
Department of PG Studies in Shalya Tantra, Sri Sri College of Ayurvedic Science and Research, 21st KM, Kanakapura road, Udayapura Post, Bengaluru- 560082
Bangalore
KARNATAKA
560082
India |
| Phone |
7619359769 |
| Fax |
|
| Email |
prithviv94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vivek J |
| Designation |
Professor |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research |
| Address |
Department of PG Studies in Shalya Tantra, Sri Sri College of Ayurvedic Science and Research, 21st KM, Kanakapura road, Udayapura Post, Bengaluru- 560082
Bangalore
KARNATAKA
560082
India |
| Phone |
9945314963 |
| Fax |
|
| Email |
ayurvedabhishak@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prithvi V |
| Designation |
PG Scholar |
| Affiliation |
Sri Sri College of Ayurvedic Science And Research |
| Address |
Department of PG Studies in Shalya Tantra, Sri Sri College of Ayurvedic Science and Research, 21st KM, Kanakapura road, Udayapura Post, Bengaluru- 560082
Bangalore
KARNATAKA
560082
India |
| Phone |
7619359769 |
| Fax |
|
| Email |
prithviv94@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Sri College Of Ayurvedic Science And Research Hospital, 21st KM, Kanakapura Road, Udayapura Post, Bengaluru- 560082. |
|
|
Primary Sponsor
|
| Name |
Dr Prithvi V |
| Address |
Department of PG Studies in Shalya Tantra, Sri Sri College of Ayurvedic Science and Research, 21st KM, Kanakapura road, Udayapura Post, Bengaluru- 560082 |
| 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 Prithvi V |
Sri Sri College Of Ayurvedic Science and Research Hospital |
Department of PG Studies in Shalya Tantra, Sri Sri College of Ayurvedic Science and Research, 21st KM, Kanakapura road, Udayapura Post, Bengaluru- 560082
Bangalore
KARNATAKA |
7619359769
prithviv94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Sri Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:S934||Sprain of ankle. Ayurveda Condition: GULPA-MARMAVIDDHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Manjishtadi Lepa, Reference: Sushrutha Samhitha, Route: Topical, Dosage Form: Sattva, Dose: 100(g), Frequency: od, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 7 Days, Reference: No, Route: -, Dosage Form: Sattva, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Dhattura Transdermal Patch, Reference: NA, Route: Topical, Dosage Form: Sattva, Dose: 100(mg), Frequency: od, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 7 Days, Reference: NA, Route: -, Dosage Form: Sattva, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects who fulfil the diagnostic criteria of ankle sprain such as history of an injury over the ankle associated with pain, swelling and restricted range of motion. Subjects with grade 1 and grade 2 ankle sprain.
2. Subjects aged between 21-60 years , irrespective of gender, religion, occupation, economic status and educational status.
|
|
| ExclusionCriteria |
| Details |
1. Subjects with fracture and dislocation of ankle joint.
2. Subjects with grade 3 ankle sprain.
3. Subjects with previous history of ligament or bone reconstructive surgery to the ankle or foot.
4. Subjects presenting with wound over the ankle along with sprain. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Marked decrease in pain in the affected ankle joint. |
1st, 3rd, 7th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduced swelling and improved range of motion in the affected ankle joint. |
7th and 14th day |
|
|
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)
|
24/07/2024 |
| 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="0"
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 HAS BEEN TAKEN UP TO EVALUATE THE EFFICACY OF DHATTURA TRANSDERMAL PATCH IN THE MANAGEMENT OF PAIN DUE SPORTS INJURY WITH SPECIAL REFERENCE TO ANKLE SPRAIN.COMPARISION WITH MANJISHTADI LEPA
HYPOTHESIS
1. NULL HYPOTHESIS: H0: THERE IS NO DIFFERENCE IN THE EFFICACY OF DHATTURA TRANSDERMAL PATCH AND MANJISHTADI LEPA IN THE MANAGEMENT OF PAIN DUE TO SPORTS INJURY WITH SPECIAL REFERENCE TO ANKLE SPRAIN.
2. ALTERNATE HYPOTHESIS H1: EFFICACY OF MANJISHTADI LEPA IS BETTER THAN DHATTURA TRANSDERMAL PATCH IN THE MANAGEMENT OF PAIN DUE TO SPORTS INJURY WITH SPECIAL REFERENCE TO ANKLE SPRAIN.
H2:
EFFICACY OF DHATTURA TRANSDERMAL PATCH IS BETTER THAN MANJISHTADI LEPA IN THE MANAGEMENT OF PAIN DUE TO SPORTS INJURY WITH SPECIAL REFERENCE TO ANKLE SPRAIN. |