FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/03/050189 [Registered on: 01/03/2023] Trial Registered Prospectively
Last Modified On: 24/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Effectiveness of Homoeopathic medicine Gaultheria procumbence in the treatment of Rheumatoid arthritis 
Scientific Title of Study   A Prospective Clinical case series study on Rheumatoid arthritis patients treated with Gaultheria procumbence 3CH by assessing C-reactive protein,Erythrocyte sedimentation rate & Rheumatoid factor. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  KAVYA M 
Designation  PG SCHOLAR 
Affiliation  Vinayaka Missions Homoeopathic Medical College and Hospital 
Address  ROOM No 3d1, Medical Unit IV, PG Department of Practice of Medicine, Ground Floor, OPD Block, Vinayaka Missions Homoeopathic Medical College and Hospital ,NH 47,Sankari Main Road, Seeragapadi PO,

Salem
TAMIL NADU
636308
India 
Phone  9446844073  
Fax    
Email  kavya.nair490@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr VenkatesanH 
Designation  Professor, Head of the Department and PG Guide 
Affiliation  Vinayaka Missions Homoeopathic Medical College and Hospital 
Address  ROOM No 3d1,Medical Unit IV, PG Department of Practice of Medicine, Ground FLOOR, OPD Block, Vinayaka Missions Homoeopathic Medical College and Hospital, NH 47, Sankari Main Road,Seeragapadi PO,

Salem
TAMIL NADU
636308
India 
Phone  9865134561  
Fax    
Email  venkathompath@gmail.com  
 
Details of Contact Person
Public Query
 
Name  KAVYA M 
Designation  PG SCHOLAR 
Affiliation  Vinayaka Missions Homoeopathic Medical College and Hospital 
Address  ROOM No 3d1,Medical Unit IV, PG Department of Practice of Medicine, Ground FLOOR, OPD Block, Vinayaka Missions Homoeopathic Medical College and Hospital, NH 47, Sankari Main Road,Seeragapadi PO,

Salem
TAMIL NADU
636308
India 
Phone  9446844073  
Fax    
Email  kavya.nair490@gmail.com  
 
Source of Monetary or Material Support  
VINAYAKA MISSION HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL, NH 47,SANKARI MAIN ROAD,SEERAGAPADI PO,SALEM,TAMILNADU-636308 
 
Primary Sponsor  
Name  VINAYAKA MISSION HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL 
Address  NH 47,SANKARI MAIN ROAD,SEERAGAPADI PO,SALEM,TAMILNADU-636308 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kavya M  VINAYAKA MISSIONS HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL  ROOM No 3d1,Medical Unit IV, PG Dept of Practice of Medicine, Ground FLOOR,OPD BLOCK,VINAYAKA MISSIONS HOMOEOPATHIC MEDICAL COLLEGE HOSPITAL,NH 47,SANKARI MAIN ROAD,SEERAGAPADI P O,
Salem
TAMIL NADU 
9446844073

kavya.nair490@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  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: M057||Rheumatoid arthritis with rheumatoid factor without organ or systems involvement,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  GAULTHERIA PROCUMBENCE 3CH  5 MEDICATED GLOBULES OF 30 SIZE PILLS WILL BE PRESCRIBED ORALLY IN MORNING AND NIGHT EVERY DAY BEFORE FOOD TO EACH PATIENT FOR 9 MONTHS 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  RHEUMATOID ARTHRITIS DIAGNOSED PATIENTS - SCORE 6 OR ABOVE IN ACR/EULAR (AMERICAN COLLEGE OF RHEUMATOLOGY - EUROPEAN LEAGUE AGAINST RHEUMATISM) CRITERIA 
 
ExclusionCriteria 
Details  PATIENTS WITH MUSCULOSKELATAL STRUCTURAL DEFORMITIES
PATIENTS UNDERGOING LONG TERM AND CONTINUING TRAETMENT FOR RHEUMATOID ARTHRITIS
PREGNANT AND LACTATING FEMALES 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
reduction in serum levels of Rheumatoid factor, ESR, and C reactive protein  9 months 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in score of Rheumatoid arthritis impact of disease (RAID) scale  9 months 
Reduction in DAS 28 score  9 months 
 
Target Sample Size   Total Sample Size="38"
Sample Size from India="38" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/03/2023 
Date of Study Completion (India) 02/08/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not Yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Rheumatoid arthritis (RA) is one among the most prevailing autoimmune disorders in India, which acts multi-dimensionally and takes a long course of one’s life span.1 Due to this nature it reduces patient’s life span and affects quality of life. The nature of disease itself calls for manifold interventions starting from Drug therapy, Physiotherapy and Surgical interventions in conventional system of treatment, which is expensive for majority of the patients. A RA patient have to spend 12.87% of his monthly income for the conventional mode of treatment.2 There are also studies showing long term side effects and contra indications for the ‘Disease Modifying Anti Rheumatic Drugs’ (DMARDs) Therapy.3 

        In Homoeopathy, many studies have contributed for the effectiveness of Homoeopathic management of Rheumatoid arthritis treated with different Homoeopathic Medicines like Ferrum picricum, Methylene blue, Salicylic acid, Gaultheria pecumbence, etc.,4,5 Among those remedies Gaultheria precumbence is a less explored remedy, which contain Salycylic acid and Methylium salicylicum as the prime active principles.6  Further more Pharmacological studies have shown that these active principles are potentially Anti-inflammatory agents.7 A Homoeopathic study have shown the Effectiveness of Gaultheria mother tincture on arthralgia patients.8 The Homoeopathic action of this Medicine on RA is well established. Yet no Scientific studies have been conducted and reported on this.

These details intended me to undertake a Research Study on the RA treated with Gaultheria precumbence 3CH. The Treatment Outcomes will be assessed with Pre and Post treatment values of Erythrocyte Sedimentation Rate (ESR), C-Reactive Protein (CRP) and Rheumatoid Factor (RF). The study will also be aiming at the Treatment assessment using Rheumatoid Arthritis Impact of Disease (RAID) SCALE9,, Disease Activity Score 28 (DAS-28) for Rheumatoid Arthritis10 and Modified Naranjo Criteria for Homeopathy-Causal Attribution Inventory (MONARCH) Score. 11

 

 

 

 

 

 

BIBLIOGRAPHY

  1.      AJMERA A. Autoimmune Disorder | National Health Portal of India [Internet]. Nhp.gov.in. 2022 [cited 1 October 2022]. Available from: https://www.nhp.gov.in/autoimmune-disorder_mtl
  2.      Syngle A, Kaur S, Verma I, Syngle T, Syngle V. Cost-effective analysis of disease-modifying anti-rheumatic drugs in rheumatoid arthritis. Clinical Rheumatology. 2017 Aug;36(8):1715-20.
  3.      Fraenkel L, Bathon JM, England BR, St. Clair EW, Arayssi T, Carandang K, Deane KD, Genovese M, Huston KK, Kerr G, Kremer J. 2021 American College of Rheumatology guideline for the treatment of rheumatoid arthritis. Arthritis & Rheumatology. 2021 Jul;73(7):1108-23.
  4.      Vangani A, Thakur A. ROLE OF RARE HOMOEOPATHIC MEDICINES; FREEUM PICRICUM, METHYLENE BLUE, SALICYLIC ACID IN THE MANAGEMENT OF RHEUMATOID ARTHRITIS.
  5.      Vithoulkas G. Clinical trial of homeopathy in rheumatoid arthritis. Homeopathy. 2011 Oct;100(04):244-52.
  6.      Michel P, Granica S, RosiÅ„ska K, Rojek J, Poraj Ł, Olszewska MA. Biological and chemical insight into Gaultheria procumbens fruits: A rich source of anti-inflammatory and antioxidant salicylate glycosides and procyanidins for food and functional application. Food & function. 2020;11(9):7532-44.
  7.      Singh1, V., Gunjan1, & Ali2, Mohammed. (2017). Isolation of volatile constituents and biological studies of aerial parts of Gaultheria procumbens L. International Journal of Green Pharmacy. Published. https://doi.org/https://doi.org/10.22377/ijgp.v11i04.1359
  8.      Agrawal DS, Bhatt DG, Adhvaryu DH, Sharma DG, Dabhi DK, Patel DJ. A study to ascertain the utility of Gaultheria procumbens mother tincture in management of post chikungunya arthropathy. International Journal of Homoeopathic Sciences. 2022;6(1):15–8.
  9.      Dougados M, Brault Y, Logeart I, van der Heijde D, Gossec L, Kvien T. Defining cut-off values for disease activity states and improvement scores for patient-reported outcomes: the example of the Rheumatoid Arthritis Impact of Disease (RAID). Arthritis research & therapy. 2012 Jun;14(3):1-4.
  10.   0. Van Riel PL, Renskers L. The Disease Activity Score (DAS) and the Disease Activity Score using 28 joint counts (DAS28) in the management of rheumatoid arthritis. Clin Exp Rheumatol. 2016 Oct;34(5 Suppl 101):S40-4.
  11.   Lamba CD, Gupta VK, van Haselen R, Rutten L, Mahajan N, Molla AM, et al. Evaluation of the modified naranjo criteria for assessing causal attribution of clinical outcome to homeopathic intervention as presented in case reports. Homeopathy. 2020;109(04):191–7.

 
Close