| CTRI Number |
CTRI/2024/11/076499 [Registered on: 08/11/2024] Trial Registered Prospectively |
| Last Modified On: |
07/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Holistic Homoeopathic Treatment in Rheumatoid Arthritis: The Role of Complete Repertory |
|
Scientific Title of Study
|
Utility of Complete Repertory in Management of Rheumatoid Arthritis |
| 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 Purviben Parmar |
| Designation |
PhD scholar |
| Affiliation |
Vidhyadeep Homoeopathic Medical College and Research Centre |
| Address |
Room no. 4, Homoeopathy department, Vidhyadeep Homoeopathic Medical College and Research Centre, Vidhyadeep University,Anita, Kim, Surat Gujarat -394110
Surat
GUJARAT
394110
India |
| Phone |
9033947458 |
| Fax |
|
| Email |
parmarpurvi66@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Purviben Parmar |
| Designation |
PhD scholar |
| Affiliation |
Vidhyadeep Homoeopathic Medical College and Research Centre |
| Address |
Room no. 4, Homoeopathy department, Vidhyadeep Homoeopathic Medical College and Research Centre, Vidhyadeep University,Anita, Kim, Surat Gujarat -394110
Surat
GUJARAT
394110
India |
| Phone |
9033947458 |
| Fax |
|
| Email |
parmarpurvi66@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr vipul shastri |
| Designation |
Principal Of VHMC and RC, I/C Provost of Vidhyadeep University, Guide |
| Affiliation |
Vidhyadeep Homoeopathic Medical College and Research Centre. |
| Address |
Room no. 4, Homoeopathy department, Vidhyadeep Homoeopathic Medical College and Research Centre, Vidhyadeep University,Anita, Kim, Surat Gujarat -394110
Surat
GUJARAT
394110
India |
| Phone |
9824109174 |
| Fax |
|
| Email |
drvipulshastri@gmail.com |
|
|
Source of Monetary or Material Support
|
| Surgery Dept, Vidhyadeep Homoeopathic Medical College and Research Centre, Anita, Kim, Surat, Gujarat, India. Pincode: 394110
|
|
|
Primary Sponsor
|
| Name |
Vidhyadeep Homoeopathic Medical College and Research Centre |
| Address |
Vidhyadeep Homoeopathic Medical College and Research Centre, Vidhyadeep University,Anita, Kim, Surat Gujarat -394110
|
| 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 Vipul R Shastri |
Vidhyadeep Homoeopathic Medical College and Research Centre |
Pathology dept, Vidhyadeep Homoeopathic Medical College and Research Centre, Vidhyadeep University,Anita, Kim, Surat Gujarat -394110
Surat
GUJARAT |
9824109174
drvipulshastri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vidhyadeep Homoeopathic Medical College and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M069||Rheumatoid arthritis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Complete Repertory-Based Homeopathic Treatment |
Homeopathic Treatment for Rheumatoid Arthritis (RA) Based on Complete Repertory
Intervention: Homeopathic remedies according to the Complete Repertory.
Dose Selection: Treatment alternatives are chosen based on participant subjective signs and overall avatar characteristics, as well as treating the participants’ joint pain, stiffness, and swelling, as well as their related stress levels.
Frequency: The frequency of administration of tablets or capsules depends on the reaction of the patient and the intensity of the symptoms, and it is changed again at each revisit.
Route of Administration: Oral.
Duration of Therapy: Four weeks, with an evaluation of the symptoms before initiation, after four weeks, and after eight weeks to determine if the dose needs to be escalated.
Outcome Goals:
Primary goal: To lower the rate of disease activity and improvements of the physical and emotional health of the patient and the client with RA.
Secondary goals: Engage in at least 3 active range of motions, decrease joint pain n stiffness, and fatigue. |
| Comparator Agent |
Standard Treatment or Placebo |
Intervention: A placebo (an inactive substance) or standard conventional therapy for RA, like NSAIDs or DMARDs, depending on the approval of the ethics committee and the randomized controlled trial study design.
Frequency and Dosage:
For placebo: Administered at the same rate as in the homeopathic group to maintain blinding of the trial.
For standard treatment: Administered based on the traditional protocol for treating RA alongside other medicines.
Route of Administration: Oral
Duration of Therapy: Eight weeks with the same assessment time points, including baseline, 4 weeks’ follow-up, and 8 weeks follow-up.
Outcome Goals:
Used in this study as the starting line to assess the outcome of the homeopathic intervention.
I also enabled bloggers to differentiate the extent of relief, quality of life, and even increase in mobility. |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
RA patients aged between all age group & sex. Patients should have confirmed RA diagnosis based on of Rheumatology criteria & RAPS.
|
|
| ExclusionCriteria |
| Details |
Patients with other types of arthritis (e.g., osteoarthritis), significant comorbid conditions (e.g., cardiovascular diseases, autoimmune diseases), or pregnancy.
Cases with irregular follow-up and non-co-operative patient.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| improvement of symptoms of Rheumatoid Arthritis |
4 Weeks: Assessment of symptoms after 4 weeks of treatment.
8 Weeks: Final assessment of symptoms after 8 weeks of treatment.
Data Collection for Results: Use data, photographs, and a standardized scale to evaluate and present the outcomes effectively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in the quality of life |
6 Months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
20/11/2024 |
| 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="0"
Months="6"
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
|
This study, titled "Holistic Approach to Rheumatoid Arthritis: Another paper of interest is "A Randomized Trial Comparing the Efficacy of the Complete Repertory in Randomised Controlled Trial": a study investigating the feasibility of homeopathic, repertory-based treatment of Rheumatoid Arthritis (RA). RA is an extended autoimmune disorder that impacts the human joints with discomfort, rigidity, inflammation, and progressive structural alteration. If left untreated, the extent of these symptoms results in severe disability and lowered quality of life and, hence, work output. Vast quantities of patients with inflammation-related diseases are treated with NSAIDs and DMARDs, whereas 75% of patients report that they still have some pain, as well as pain related to stress and mental disorders.
This present study aims to look into a holistic approach through homeopathy, particularly Complete Repertory. This extensive book may guide the clinician more specifically concerning the physical and psychological lesion in the homeopathic case. In this cross-sectional descriptive study, 100 patients with RA were confirmed clinically, serologically, and through imaging studies at Vidhyadeep Homoeopathic Hospital in Kim. All participants are then voluntarily assigned to the group for the comprehensive treatment plan mapped to their specific manifesting discomforts and potential sources of stress in life, and various treatments are employed in the Complete Repertory.
The main parameters in the study include decreases in joint pain and stiffness and the capability of enhancing the quality of life using the Rheumatoid Arthritis Pain Scale (RAPS) and other related tools. Data is obtained during follow-up visits to assess short-term and long-term changes. A quantitative approach will compare pre- and post-intervention scores using the paired t-test on pain, mobility, and overall mental status. As a result, this study proposes a strategy to explore the efficacy/safety of homeopathic repertory-based treatment as complementary and holistic alongside conventional treatment methods in reducing the impact of RA. |