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 |
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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
|
|
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 |
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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: 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
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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 - 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
- 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.
- 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.
- Vangani A, Thakur A. ROLE OF RARE HOMOEOPATHIC MEDICINES; FREEUM PICRICUM, METHYLENE BLUE, SALICYLIC ACID IN THE MANAGEMENT OF RHEUMATOID ARTHRITIS.
- Vithoulkas G. Clinical trial of homeopathy in rheumatoid arthritis. Homeopathy. 2011 Oct;100(04):244-52.
- Michel P, Granica S, RosiÅ„ska K, Rojek J, Poraj Å, 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.
- 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
- 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.
- 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.
- 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.
- 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.
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