| CTRI Number |
CTRI/2025/03/082811 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
16/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Mahavishagarbha taila in the pain and stiffness of bone fracture |
|
Scientific Title of Study
|
Efficacy of Mahavishagarbha taila in the management of post immobilization pain and stiffness of wrist fracture |
| 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 Jahangir Alom |
| Designation |
PG scholar |
| Affiliation |
Govt. Ayurvedic College and hospital Guwahati Assam |
| Address |
Govt. Ayurvedic college and hospital Guwahati Assam
PIN 781014
Govt. Ayurvedic College and Hospital Guwahati Assam
PIN 781014
Kamrup
ASSAM
781014
India |
| Phone |
7002960211 |
| Fax |
|
| Email |
jahangirusb@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pankaj Kumar Barman |
| Designation |
Professor and HOD Department of Shalya tantra |
| Affiliation |
Govt ayurvedic college Jalukbari Guwahati 14 |
| Address |
Govt ayurvedic college and hospital Jalukbari Guwahati 14
Assam
PIN 781014
Kamrup
ASSAM
781014
India |
| Phone |
838781329 |
| Fax |
|
| Email |
drpankajbarman@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pankaj Kumar Barman |
| Designation |
Professor and HOD Department of Shalya tantra |
| Affiliation |
Govt ayurvedic college Jalukbari Guwahati 14 |
| Address |
Govt ayurvedic college and hospital Jalukbari Guwahati 14
Assam
PIN 781014
Kamrup
ASSAM
781014
India |
| Phone |
838781329 |
| Fax |
|
| Email |
drpankajbarman@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic College and hospital Jalukbari Guwahati 14 |
|
|
Primary Sponsor
|
| Name |
Govt ayurvedic college and hospital |
| Address |
Jalukbari
Guwahati
Assam PIN 781014 |
| 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 Pankaj Kumar Barman |
Govt Ayurvedic college and Hospital Jalukbari Guwahati 14 |
OPD and IPD of Shalya tantra department
Kamrup
ASSAM |
8638781329
drpankajbarman@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee Govt Ayurvedic college Jalukbari Guwahati 14 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M219||Unspecified acquired deformity oflimb and hand. Ayurveda Condition: BAGNAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Physiotherapy with muscle exercise | After removal POP cast the patient is undergone physiotherapy and muscle exercise | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Mahavishagarbha taila, Reference: Baisajya ratnavali vatavyadhi rogadhikar , Route: Topical, Dosage Form: Taila, Dose: 30(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 10 Days, anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Pateint of age group 16 - 60 years both healthy male and female
|
|
| ExclusionCriteria |
| Details |
Malunion
Nonunion
Neuropathy
Metabolic disease of bone |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease the symptom of pain and swelling of post immobilisation wrist fracture |
Time period of 15 - 20 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease the symptom of pain and swelling of post immobilisation wrist fracture |
15 - 20 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
|
N/A |
|
Date of First Enrollment (India)
|
27/04/2025 |
| 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="2"
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 is open randomized single centre trial comparing the efficacy of Mahavishagarbha taila in the management of post immobilization pain and stiffness of wrist fracture with conventional physiotherapy for 15 to 20 days . The study will be conducted in india only |