| CTRI Number |
CTRI/2024/11/076855 [Registered on: 14/11/2024] Trial Registered Prospectively |
| Last Modified On: |
01/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study to test the effectiveness of homoeopathic remedies of Cimcifuga Racemosa and Rhododendron Chrysanthum in treating trapezitis. |
|
Scientific Title of Study
|
A Comparative Study To Assess The Efficacy Of Cimcifuga Racemosa 1 M And Rhododendron Chrysanthum 1 M In Cases Of Trapezitis - A Clinical Study In The Age Group Of 20-50 Years |
| 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 Sumi TS |
| Designation |
PG Scholar |
| Affiliation |
Bharati Vidyapeeth Deemed To Be University Homoeopathic Medical College And Hospital |
| Address |
Bharati Vidyapeeth Deemed To Be University Homoeopathic Medical College And Hospital, Katraj-Dhankawadi,Pune-411043. Department Of Homoeopathic Materiamedica.
Pune
MAHARASHTRA
411043
India |
| Phone |
7539944453 |
| Fax |
|
| Email |
sumithankamony@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neha V Jadhavrao |
| Designation |
Assistant Professor |
| Affiliation |
Bharati Vidyapeeth Deemed To Be University Homoeopathic Medical College And Hospital |
| Address |
Bharati Vidyapeeth Deemed To Be University Homoeopathic Medical College And Hospital, Katraj-Dhankawadi,Pune-411043. Department of Homoeopathic MateriaMedica.
Pune
MAHARASHTRA
411043
India |
| Phone |
9923003441 |
| Fax |
|
| Email |
neha.jadhavrao@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sumi TS |
| Designation |
PG Scholar |
| Affiliation |
Bharati Vidyapeeth Deemed To Be University Homoeopathic Medical College And Hospital |
| Address |
Bharati Vidyapeeth Deemed To Be University Homoeopathic Medical College And Hospital, Katraj-Dhankawadi,Pune-411043. Department of Homoeopathic Materiamedica.
Pune
MAHARASHTRA
411043
India |
| Phone |
7539944453 |
| Fax |
|
| Email |
sumithankamony@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth Deemed To Be University Homoeopathic Medical College And Hospital Katraj, Dhankawadi, Pune-411043 |
|
|
Primary Sponsor
|
| Name |
Dr. Sumi T S |
| Address |
Bharati Vidyapeeth Deemed To Be University Homoeopathic Medical College And Hospital Katraj, Dhankawadi, Pune-411043 |
| 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 Sumi T S |
BVDU Homoeopathic Medical College, Department of Post Graduate and Research Centre |
Homoeopathic Materia Medica
OPD, Department of
Homoeopathic Materia Medica ,
Pune-Satara Road,
Dhankawadi, Katraj,
Pune-43
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
07539944453
sumithankamony@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instutional Ethics Committee Bharati Vidyapeeth (DTU)HMC Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M628||Other specified disorders of muscle, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Cimcifuga Racemosa |
Cimcifuga Racemosa -Potentised Homoeopathic medicine Cimcifuga Racemosa- given in the form of pills. Dose : 1 Dose followed by four pills BD.Potency:1M. Route of administration: Oral. Duration of therapy : 3 months. |
| Intervention |
Rhodendron Chrysanthum |
Rhodendron Chrysanthum-Potentised Homoeopathic medicine Rhodendron Chrysanthum- given in the form of pills.
Dose : 1 Dose followed by four pills BD.Potency:1M.
Route of administration: Oral.
Duration of therapy : 3 months. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Age group 20-50 years.
2. Both Sexes.
3. Patient who willing to give consent.
4. Those cases fulfilling case definition. |
|
| ExclusionCriteria |
| Details |
1. Age less than 20 and more than 50.
2. Pregnant and Lactating mothers.
3.Past medical history of any other musculoskeletal diseases, malignancy and HIV cases are excluded. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the improvement of symptoms of trapezitis by using Cimcifuga Racemosa 1M and Rhodendron Chrysanthum 1M. |
3 months with followup in each 15 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the intensity of symptoms by Visual Analogue Scale. |
3 months with followup in each 15 days. |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
25/11/2024 |
| 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="6"
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
|
This is a single blind randomized control study. The primary objective of the study is to assess the improvement of symptoms of trapezitis by using Cimcifuga Racemosa 1M and Rhodendron Chrysanthum 1M.Minimum 52 patients from Bharati Vidyapeeth( Deemed to be University) Homoeopathic Medical College and Hospital will be enrolled in the study.52 patients are split into two groups. 26 receiving Cimcifuga Racemosa 1M and 26 receiving Rhododendron Chrysanthum 1M. Randomisation will occur through Lottery method. Followup occurs every 15 days for 3 months.Before and After pain will be assessed by Visual Analogue Scale. |