| CTRI Number |
CTRI/2024/05/067340 [Registered on: 14/05/2024] Trial Registered Prospectively |
| Last Modified On: |
06/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
The effect of Mud Lepa in rheumatoid arthritis
|
|
Scientific Title of Study
|
Evaluation of The Individual and Combined Effect of Mritika Lepa and oral Ayurveda Drugs on Pain Alleviation and Modulation of Inflammatory Markers in Rheumatoid Arthritis A Pilot Clinical Study |
| 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 Durgawati Devi |
| Designation |
Professor and HOD |
| Affiliation |
National Institute of Ayurveda |
| Address |
room no 205 Dept of Swasthavritta and Yoga amber road jorawar singh gate National Institute of Ayurveda
Jaipur
RAJASTHAN
302002
India |
| Phone |
7073746600 |
| Fax |
|
| Email |
dvd6197@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anant Ram Ahirwar |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Ayurveda |
| Address |
room no 205 Dept of Swasthavritta and Yoga amber road jorawar singh gate
Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
7566008123 |
| Fax |
|
| Email |
anantahirwar2016@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Durgawati Devi |
| Designation |
Professor and HOD |
| Affiliation |
National Institute of Ayurveda |
| Address |
room no 205 Dept of Swasthavritta and Yoga amber road jorawar singh gate National Institute of Ayurveda
Jaipur
RAJASTHAN
302002
India |
| Phone |
7073746600 |
| Fax |
|
| Email |
dvd6197@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda Jorawar singh gate Amber road jaipur 302002 |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda |
| Address |
jorawar singh gate amber road national institute of ayuveda jaipur 302002 |
| Type of Sponsor |
Government 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 Durgawati devi |
National Institute of Ayurveda |
OPD no 21 Dept of Swasthavritta and Yoga National Institute of Ayurveda amber road jorawar singh gate National Institute of Ayurveda
Jaipur
RAJASTHAN |
7073746600
dvd6197@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee national institute of ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M058||Other rheumatoid arthritis with rheumatoid factor. Ayurveda Condition: AMAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Sinhanada Guggulu, Reference: Bhaishjya Ratnavali amavatadhikar, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 2 Weeks, anupAna/sahapAna: Yes(details: luke warm water), Additional Information: -(2) Medicine Name: Rasnasaptak Kwath , Reference: Bhaishjya Ratnavali amavatadhikar, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 2 Weeks, anupAna/sahapAna: Yes(details: luke warm water), Additional Information: | | 2 | Comparator Arm (Non Ayurveda) | | - | Mritika lepa | Mritika Lepa on affected joints with pain stiffness and inflammation once a day in morning at empty stomach for 20 to 30 minutes for 2 weeks | | 3 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Sinhanada Guggulu , Reference: Bhaishjya Ratnavali amavatadhikar chapter no 29 shlok no 190 to195,, Route: Oral, Dosage Form: Guggulu , Dose: 1(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 2 Weeks, anupAna/sahapAna: Yes(details: Rasnasaptak Kwath 40 ml), Additional Information: Mritika Lepa on affected joints with pain stiffness and inflammation once a day in morning at empty stomach for 20 to 30 minutes also given along with medicibne |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18 to 60 years of either sex
Confirmed and diagnosed cases of Rheumatoid Arthritis based on established criteria e g American College of Rheumatology/European League Against Rheumatism criteria
Active disease status as indicated by a Disease Activity Score DAS28 of more than or equal to 3 point 2
Chronic cases up to 5 years
|
|
| ExclusionCriteria |
| Details |
Pregnant or lactating individuals due to potential risks associated with the treatments
Known contraindications or allergy to any of the study drugs contents or Mritika Lepa
Presence of significant comorbidities such as uncontrolled diabetes hypertension renal or hepatic impairment which may interfere with the assessment of study outcomes
Coexistence of other autoimmune diseases
e g systemic lupus erythematosus that may confound the assessment of Rheumatoid Arthritis outcomes
Severe joint damage or deformities that may limit accurate pain assessment or interfere with the treatment outcomes
Use of systemic immunosuppressive agents within the last three months prior to enrolment
Recent major surgery within the last three months that may impact the study outcomes
Participation in another clinical trial within 30 days before screening
Inability to comply with the study procedures or follow-up visits
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in pain intensity measured using a standardized pain scale |
Change in pain intensity measured using a standardized pain scale in two weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Changes in inflammatory biomarker levels like C reactive protein erythrocyte sedimentation rate and complete blood count
2 Improvement in functional status using disease specific assessment tools DAS 28 Score for Rheumatoid Arthritis
3 Incidence of adverse events and side effects associated with the use of Oral Ayurveda drugs and Mritika Lepa and their combination in patients with Rheumatoid Arthritis
|
2 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
03/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
03/06/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Need of study • Rheumatoid Arthritis is one of the leading problems in middle aged group in the world. The prevalence of Rheumatoid arthritis worldwide is 0.5 to 1% of total population. In India there is about 1.3 crore patients in 2021 according to various studies. So, this is the leading health problem world-wide and also in India that affects the normal functions of people. • No satisfactory management of RA has found till now in contemporary sciences. Many studies related to the Rheumatoid Arthritis has been conducted in the field of Ayurveda. Many successful Ayurvedic treatment procedures and protocols are also established. • There are many Lepas developed for Rheumatoid Arthritis. All these treatments procedures are relatively complex, many needing hospitalization and are a bit expensive as compared to Mritika Chikitsa. Hypothesis behind the planning of this research work is to provide an alternative treatment procedure to the patients. • So, this study is planned as an attempt to evaluate the effect of Mritika Chikitsa in Rheumatoid Arthritis that is relatively less expensive, less complicated, needs no hospitalization and is easily available. • Aim: To evaluate the effect of Mritika Chikitsa in Rheumatoid Arthritis.The aim of this study is to assess and compare the pain alleviating and inflammatory markers modulating effects in patients with Rheumatoid Arthritis who receive therapy with oral Ayurveda drugs alone, Mritika Lepa alone, and the combination of oral Ayurveda drugs and Mritika Lepa. • Objective: 1.To evaluate the efficacy of oral Ayurveda drugs (Rasnasaptak kwath and singhanad guggulu) in providing pain relief and modulating inflammatory markers in patients with Rheumatoid Arthritis. 2. To assess the efficacy of Mritika Lepa in alleviating pain and modulating inflammatory markers in patients with Rheumatoid Arthritis. 3. To investigate the combined efficacy of Oral Ayurveda drugs and Mritika Lepa on pain alleviation and modulation of inflammatory markers in patients with Rheumatoid Arthritis. 4.To compare the individual and combined therapies to identify potential synergistic effects for pain relief and inflammatory marker modulation in Rheumatoid Arthritis. 5. To provide preliminary evidence for guiding future larger-scale clinical trials and treatment recommend Research Question : Inflammations for Rheumatoid Arthritis management. Null Hypothesis:H0 - There is no difference in pain alleviation and modulation of inflammatory markers among patients with Rheumatoid Arthritis who receive therapy with Oral Ayurveda drugs alone, Mritika Lepa alone, and the combination of Oral Ayurveda drugs and Mritika Lepa. STUDY DESIGN : 60 patients with 20 patients in each group. • Total duration of study: 18 MONTHS • Recruitment period: 12 MONTHS • Treatment period: 02 WEEKS • Follow up: EVERY WEEK (During Treatment) • Type of study: Interventional • Intervention and comparator agent : • Group A: Rasna saptak kwath 40 ml twice a day in morning and evening at empty stomach along with sinhanada guggulu 2 tab each of 500 mg twice a day in morning and evening for 2 weeks • Group B: Mritika Lepa on affected joints with pain, stiffness and inflammation once a day in morning at empty stomach for 20-30 minutes for 2 weeks • Group C: Both above treatments for 2 weeks • Reference – Madhava nidana , amavatanidan, 1-6, chapter 25 |