| CTRI Number |
CTRI/2024/11/077049 [Registered on: 19/11/2024] Trial Registered Prospectively |
| Last Modified On: |
07/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to check the efficacy and safety of investigational product in the management of rheumatoid arthritis. |
|
Scientific Title of Study
|
A randomized, double blind, placebo controlled clinical study to evaluate the efficacy & safety of the investigational product in rheumatoid arthritis. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MHC/CT/24-25/027 version 1.00; dated 20 July 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ameya Pathak |
| Designation |
Principal Investigator |
| Affiliation |
Sangvi Multispeciality Hospital Pvt. Ltd. |
| Address |
Sangvi Multispeciality Hospital, OPD room no 01,1st floor,Krushna
Chowk, Krushna Nagar, New Sangvi
Pune MAHARASHTRA 411027 India |
| Phone |
9873017652 |
| Fax |
- |
| Email |
dramey.sangvihospital@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Mrs Shilpa Risbud |
| Designation |
GM- Research & QA |
| Affiliation |
Advanced Vital Enzymes P. Ltd. (Advenza) |
| Address |
Unit no. 424, 4th Floor, Lodha Supremus II, Road no. 22, Wagle Industrial Estate, Thane (W)
Thane MAHARASHTRA 400604 India |
| Phone |
2249708404 |
| Fax |
- |
| Email |
shilpa@advenza.co.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Gayatri Ganu |
| Designation |
Director |
| Affiliation |
Mprex Healthcare Pvt. Ltd. |
| Address |
501, 514 Crossroads, Bhumkar square, Wakad
Pune MAHARASHTRA 411057 India |
| Phone |
8554912644 |
| Fax |
- |
| Email |
drgayatri@mprex.in |
|
|
Source of Monetary or Material Support
|
| Advanced Vital Enzymes P. Ltd. (Advenza) Unit no. 424, 4th Floor, Lodha Supremus II, Road no. 22, Wagle Industrial Estate, Thane (W) - 400604, India |
|
|
Primary Sponsor
|
| Name |
Advanced Vital Enzymes P. Ltd. (Advenza) |
| Address |
Unit no. 424, 4th Floor, Lodha Supremus II, Road no. 22, Wagle Industrial Estate, Thane (W) - 400604, India |
| Type of Sponsor |
Other [Nutraceutical] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Amol Shinde |
Care Multispecialty Hospital |
Kolte Arcade, Pune Nagar road, Wagholi Pune MAHARASHTRA |
8275589013 - dramolshinde936@gmail.com |
| Dr Ameya Pathak |
Sangvi Multispeciality Hospital Pvt. Ltd |
Sangvi Multispeciality Hospital, OPD room no 01,1st floor,Krushna
Chowk, Krushna Nagar, New Sangvi Pune MAHARASHTRA |
9873017652 - dramey.sangvihospital@gmail.com |
| Dr Shweta Khopde |
Vivekanand Hospital |
Dhanore Phata, Alandi-Markal road Pune MAHARASHTRA |
9594340931 - dr.shwetavivekanandhospital@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Care Multispecialty Hospital Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee Lokmanya Medical Research Centre |
Approved |
| Institutional Ethics Committee Sangvi Multispeciality Hospital |
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 |
One EnMax DS tablet + Standard of care (DMARDs i.e. methotrexate, leflunomide, hydroxychloroquine, and sulfasalazine alone or in combination) |
Twice daily, on an empty stomach with 240 ml of water, either 30 minutes before or 60 minutes after breakfast & dinner. |
| Comparator Agent |
One Placebo + Standard of care (DMARDs i.e. methotrexate, leflunomide, hydroxychloroquine, and sulfasalazine alone or in combination) |
Twice daily, on an empty stomach with 240 ml of water, either 30 minutes before or 60 minutes after Breakfast & dinner. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and female participants 30-60 years of age (both inclusive), who present RA (rheumatoid arthritis), diagnosed according to ACR or EULAR 2010 criteria;2.Mild to moderate disease activity, according to DAS 28 (Erythrocyte Sedimentation Rate ESR) greater than an equal to 3.2;3. Participant exhibiting clinically apparent symptoms such as joint swelling and tenderness greater than an equal to 6 weeks;4. Participant on stable medication that is DMARDs that is methotrexate, leflunomide, hydroxychloroquine, and sulfasalazine greater than an equal to 3 months for RA;5. Participants having VAS score in between 4 to 8;6. Willing to give informed consent for the study. |
|
| ExclusionCriteria |
| Details |
1. Participants with other systemic complications of RA like rheumatic heart disease (RHD), rheumatic fever, pleural pericardial disease;2. Participants diagnosed with other arthritis like gouty arthritis, and tuberculous arthritis. However, participants with radiologically confirmed osteoarthritis may be excluded at the investigators discretion if the severity of OA is judged to interfere with the study assessment;
3. Allergy, sensitivity, or contraindication to interventional product;
4.Participants receiving anticoagulant and or antiplatelet agents;
5.Participants who are unable to walk without support and or confined to a wheelchair;
6.Past history of TNF (tumor necrosis factor) blocking agents or other biologic treatment;
7.Chronic antibiotic therapy, if the investigator considers this may affect the safety of the subject or the assessment of the study results;
8.History of psychiatric disorder that may impair the ability of participant to provide written informed consent;
9.A history presenting RA encompassing more than a year;
10.Participation in any RA related or any other trials involving investigational products within 30 days prior to the screening visit;
11.Participants treated with any investigational drug in the preceding 4 weeks;
12.Female participants with a positive pregnancy test or lactating;
13.History of drug abuse or dependence;
14.History of septic arthritis within a native joint within the last 12 months;
15.Presence of a transplanted organ;
16.Participants unable to comply with the treatment regimen;
17.Participant currently using any enzyme, nutraceutical, ayurvedic, herbal supplement for RA;
18.Participants with any other condition that, in the opinion of the investigator, does not justify the inclusion of the participant in the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Assessment of disease activity score (DAS-28)
2. Changes in Visual Analogue Scale (VAS) pain score
3. Assessment of changes in the duration of the morning stiffness (minutes) |
1. At screening, day 1, day 15, day 30, and day 45.
2. At screening, day 1, day 15, day 30, and day 45.
3. At day 1, day 15, day 30 and day 45.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Changes in biomarkers such as TNF-Alpha, IL-1, IL-6, hsCRP, MMP 3, ESR
2. Changes in physician’s global assessment score
3. Changes in requirement of analgesic as a rescue medication
4. Assessment of Indian version of the Health Assessment Questionnaire (HAQ-DI) disability index score
5. Changes in symptom score on 4- point Linkert scale for symptoms of heartburn, gastric discomfort & epigastric pain |
1. At day 1 and day 45.
2. At day 45.
3. At day 1, day 15, day 30, and day 45.
4. At day 1, day 15, day 30, and day 45.
5. At day 1, day 15, day 30 and day 45. |
|
|
Target Sample Size
|
Total Sample Size="106" Sample Size from India="106"
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)
|
25/11/2024 |
| 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="3" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
RA is a chronic disease that has multiple and fluctuating symptoms. Because no one measure can adequately capture disease activity or severity. Proteolytic
enzymes in RA are grounded in their observed anti-inflammatory properties,
which can potentially mitigate the chronic inflammation characteristic of RA
joints. These enzymes, such as bromelain, papain, trypsin, and chymotrypsin,
may modulate inflammatory pathways by degrading cytokines and other
inflammatory mediators. Additionally, they show promise in promoting tissue
repair and regeneration, essential for combating joint damage and erosion in
RA. Studies suggest that proteolytic enzymes could help restore immune balance by
influencing cytokine profiles and immune cell function. Clinical evidence
supports their role in reducing pain and improving joint function, offering a
complementary therapeutic approach alongside conventional RA treatments.
This
trial is also designed to investigate whether oral proteolytic enzymes could
provide systemic relief from gastrointestinal symptoms, which are commonly
associated with the DMARDs. Specifically, the study aimed to assess the
enzymes’ potential in alleviating heartburn, gastric discomfort, and epigastric
pain in individuals with rheumatoid arthritis, offering a potentially safer
alternative or adjunct to conventional DMARD therapy.
Moreover,
their natural origin often ensures better tolerability and safety profiles
compared to synthetic medications, making them appealing for participants
seeking alternative or adjunctive therapies for RA management. The aim of the
study was to evaluate the efficacy and safety of an oral enzyme supplement
(EnMax DS) with the placebo. |