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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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)”. 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.

 
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