| CTRI Number |
CTRI/2018/04/013059 [Registered on: 05/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
24/03/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Therapeutical] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical study on healing of Radius fracture by combined use of Murivenna and Trayodashanga guggulu along with posterior slab |
|
Scientific Title of Study
|
An open label Clinical study to evaluate the combined effect of Trayodashanga guggulu and Murivenna with standard care in healing of Radius fracture |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amrita M Nandakumar |
| Designation |
Doctor |
| Affiliation |
Amrita School of Ayurveda |
| Address |
Anand,Vinayaka Nagar
Edappally,Kochi-24
Amrita School of Ayurveda
Clappana P.O,Vallickavu,
Kollam
690525
Kollam
KERALA
682024
India |
| Phone |
9847385044 |
| Fax |
0476-2899681 |
| Email |
dramrita712@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rabinarayan Tripathy |
| Designation |
Doctor |
| Affiliation |
Amrita School of Ayurveda |
| Address |
Amrita School of Ayurveda
Amritapuri;Amrita Viswa vidyapeetham,India
Amrita School of Ayurveda
Clappana P.O,Vallickavu,
Kollam
690525
Kollam
KERALA
690525
India |
| Phone |
8129292391 |
| Fax |
0476-2899681 |
| Email |
drrabi73@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Amrita M Nandakumar |
| Designation |
Doctor |
| Affiliation |
Amrita School of Ayurveda |
| Address |
Anand,Vinayaka Nagar
Edappally,Kochi-24
Amrita School of Ayurveda
Clappana P.O,Vallickavu,
Kollam
690525
Kollam
KERALA
682024
India |
| Phone |
9847385044 |
| Fax |
0476-2899681 |
| Email |
dramrita712@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita School of Ayurveda , Amritapuri ,Amrita Viswa vidyapeetham,India |
|
|
Primary Sponsor
|
| Name |
Amrita School of Ayurveda |
| Address |
Amrita school of Ayurveda
Clappana P.O,Vallikavu,Kollam-690525 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Amrita M Nandakumar |
Amrita School of Ayurveda |
Amrita School of Ayurveda
Clappana P.O,Vallickavu
Kollam
Kollam
KERALA |
9847385044
0476-2899681
dramrita712@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Amrita Institue of medical sciences,Institutinal ethical committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Fracture of Radius bone, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Muirvenna 5ml once daily over posterior slab and Trayodashangag guggulu 500mg after food with warm water |
Muirvenna 5ml once daily over posterior slab and Trayodashangag guggulu 500mg after food with warm water for 45days |
| Comparator Agent |
Posterior slab alone |
Posterior slab alone for 45days |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with simple fractures of radius
Fracture of history of trauma
Fracture diagnosed by radiograph |
|
| ExclusionCriteria |
| Details |
Patients having other systemic pathology(Tuberculosis,Osteoporosis)
Multiple,compound or comminuted fracture,Fracture that requires surgical intervention
Fracture associated with visceral injury
Both bone fracture |
|
|
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 |
| Reduction in pain,tenderness,swelling,deformity.Improves loss of function,callus formation,bone trabeculi,RUST score,RUSH score |
Assessed on 0th day and 45thday (Before and after treatment(45days) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improves Quality of Life,Enhances movements |
Improves quality of Life,Enhances movements |
|
|
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)
|
21/10/2016 |
| 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="0"
Months="1"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
Not yet published. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is proposed to compare the combined efficacy of trayoadasanga guggulu and Murivenna application in fracture of radius over standard care available now. Study design- open label clinical trial,Sampling technique- simple random sampling.30 Patients will be selected and will be randomly allocated in 2 equal groups based on inclusion and exclusion criteria.In G1- Immobilisation with posterior slab,Murivenna application once daily approximately 10ml over it and Trayodasanga guggulu (1-0-1) 500mg before food.In G2-Patients will be given standard care available.The changes will be noted in the specially prepared case sheet.The observations will be analysed on the basis of assessment parameters critically and scientifically,before,during and after treatment.Result will be analysed statistically by Paired T test for its significance. |