| CTRI Number |
CTRI/2025/02/080939 [Registered on: 20/02/2025] Trial Registered Prospectively |
| Last Modified On: |
11/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeopathic medicine Rhus toxicodendron in pain of muscles and bones. |
|
Scientific Title of Study
|
Assessment of likelihood ratio of four characteristic Symptoms of Rhus toxicodendron of Musculoskeletal Disorders (MSD) |
| 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 Suraia Parveen |
| Designation |
Research officer (H)/S-3, |
| Affiliation |
Dr Anjali Chatterji Regional Research Institute for Homoeopathy |
| Address |
Dr. Anjali Chatterji Regional Research Institute for Homoeopathy
50,Rajendra Chatterjee road
Kolkata
WEST BENGAL
700035
India
Kolkata WEST BENGAL 700035 India |
| Phone |
7001510319 |
| Fax |
|
| Email |
drsuraiya2009@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Suraia Parveen |
| Designation |
Research officer (H)/S-3, |
| Affiliation |
Dr Anjali Chatterji Regional Research Institute for Homoeopathy |
| Address |
Dr. Anjali Chatterji Regional Research Institute for Homoeopathy
50,Rajendra Chatterjee road
Kolkata
WEST BENGAL
700035
India
Kolkata WEST BENGAL 700035 India |
| Phone |
7001510319 |
| Fax |
|
| Email |
drsuraiya2009@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Suraia Parveen |
| Designation |
Research officer (H)/S-3, |
| Affiliation |
Dr Anjali Chatterji Regional Research Institute for Homoeopathy |
| Address |
Dr. Anjali Chatterji Regional Research Institute for Homoeopathy
50,Rajendra Chatterjee road
Kolkata
WEST BENGAL
700035
India
Kolkata WEST BENGAL 700035 India |
| Phone |
7001510319 |
| Fax |
|
| Email |
drsuraiya2009@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central council for research in Homoeopathy, NEW DELHI |
|
|
Primary Sponsor
|
| Name |
Central council for research in Homoeopathy |
| Address |
61-65, Institutional area, Janakpuri, New Delhi-110058
|
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Suraia Parveen |
Dr. Anjali Chatterji Regional Research Institute |
Room no 4 Department
Homoeopathy Division
Clinical research, 50,
Rajendra Chatterji
Road Kolkata-700035
Kolkata
WEST BENGAL Kolkata WEST BENGAL |
7001510319
drsuraiya2009@gmail.com |
| Dr Sonia Raizada |
Dr. DP Rastogi Central Research Institute (Homoeopathy), Noida |
A-1, SECTOR
24,GAUTAMBUDH
NAGAR,
NOIDA-201301
Gautam Buddha Nagar
UTTAR PRADESH Gautam Buddha Nagar UTTAR PRADESH |
9717213679
drsoniaraizada@gmail.com |
| Dr Ranjit Sonny |
Regional Research Institue(Homoeopathy), Siliguri, WB |
M9JM+7JG, Chota Pathuram, West Bengal 734011 Jalpaiguri WEST BENGAL |
9883203656
drranjitsonnymd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| CENTRAL ETHICS COMMITTEE |
Approved |
| Institutional Ethics Committee Regional Research Institute for Homoeopathy, Siliguri |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE DACRRI KOLKATA |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE DDPRCRI, NOIDA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M059||Rheumatoid arthritis with rheumatoid factor, unspecified, (2) ICD-10 Condition: M150||Primary generalized (osteo)arthritis, (3) ICD-10 Condition: M255||Pain in joint, (4) ICD-10 Condition: M479||Spondylosis, unspecified, (5) ICD-10 Condition: M659||Synovitis and tenosynovitis, unspecified, (6) ICD-10 Condition: M629||Disorder of muscle, unspecified, (7) ICD-10 Condition: M715||Other bursitis, not elsewhere classified, (8) ICD-10 Condition: M109||Gout, unspecified, (9) ICD-10 Condition: M138||Other specified arthritis, (10) ICD-10 Condition: M949||Disorder of cartilage, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
and other Homoeopathic medicines |
Rhus toxicodendron and other Homoeopathic medicines in
centesimal potencies shall be
used in the trial.
The dose of the medicine will be
given as per the
patients requirement. Each dose of indicated
medicine shall consist of 4
globules (size no. 30). Intervention
medicines will be administered
orally. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Age between 18-70 years
2. Both sexes
3. Patients are suffering from any type of Musculoskeletal Disorders (Diagnosis is based clinically and physical examination; with or without imaging or other evidences).
4. Patients willing to give written consent for participation in the study.
5. Patients with controlled metabolic and systemic diseases.
6. Wash-out period of at least two weeks for any ongoing conventional medicines
|
|
| ExclusionCriteria |
| Details |
1. Unwillingness of Patients to participate or to comply with the study requirements.
2. Pregnant women or lactating mother
3. Psychiatric illness
4. Self reported immunocompromised state,
5. Drug or substance abuse or dependence.
• Other uncontrolled or advanced pulmonary Diabetes mellitus, systemic diseases or pathologies affecting quality of life.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The Likelihood ratio of four symptoms of Rhus toxicodendron as mentioned will be estimated as per the patient-rated outcomes through ORIDL Scales and MYMOP-2. |
at base line, after 6 months of treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Evaluate the positive responses of Homoeopathic intervention in patient with Musculoskeletal disorders using ORIDL score & MYMOP2 score
2. Assessment of the pain intensity by NRS in patients with Musculoskeletal disorders.
3. Validate the four (4) characteristic symptoms of Rhus toxicodendron as mentioned
|
baseline, monthly for 6 months |
|
|
Target Sample Size
|
Total Sample Size="1200" Sample Size from India="1200"
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 |
|
Date of First Enrollment (India)
|
22/02/2025 |
| 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="3" 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
|
It is a prospective,
observational, open label patient outcome study for patients suffering from
Musculoskeletal Disorders entitled “Assessment of likelihood ratio of four
characteristic Symptoms of Rhus toxicodendron of Musculoskeletal
Disorders (MSD)â€. The reliability
of homeopathic prescriptions may increase through resource to characteristic
signs and symptoms with significant positive likelihood ratio (LR) results
may increase the reliability of homeopathic
prescriptions. In this study
we will estimate the LR for four characteristic symptoms of Rhus toxicodendron which will attribute to the homeopathic
medicine Rhus tox in treatment for MSD. It is multi-centric
observational assessment, will be conducted at Dr Anjali Chatterji Regional
Research Institute (H), Kolkata , DDPR Central Research Institute (H), Noida
and Regional Research Institute (H), Siliguri. All participants in the age
group of 18 to 70 years having symptoms of any MSD will be studied. Here, LR will
be assessed based on Bayesian statistics of four characteristic symptoms of Rhus toxicodendron in treatment for MSD.
Here we will investigate the
prevalence of four symptoms (i.e. Ailments from strains/over
lifting/overstretching and over exertion 2. Pain < first movement >
motion 3. Pain from warm application. 4. Great apprehension at night, cannot remain in bed) in the general patient population (all
MSD) and among good responders to Rhus tox in daily homeopathic
treatment and estimate LR for these four symptoms of Rhus tox. Rhus tox and Individualized Homoeopathic medicine in
centesimal potencies manufactured by a licensed homoeopathic pharmaceutical company
approved by the Council. |