Effect Of Moringa Leaf Extract On Disease Activity In Rheumatoid Arthritis Patients
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 1
Locations
Indonesia
Study Type
Interventional
Intervention
Moringa Oleifera
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria: Diagnosis of RA criteria according to the ACR / EULAR 2010 Visual analog score of more than three. Exclusion Criteria: Pregnancy Using Methylprednisolone> 8 mg per day Using NSAIDs Chronic Kidney Disease Diabetes Mellitus Heart Failure Lever disease
Sites / Locations
- RS UNS (Universitas Sebelas Maret Hospital)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Moringa Oliefera
Placebo
Arm Description
Intervention with Dry Extract of Moringa Oleifera (trade name is Keloreena Ⓡ , registered number in National Food and Drug Registry: 193332021) The dose given is 1000 mg bi in day for 30 days.
Capsules similar to moringa oliefera, which contain powder, have no pharmacological effect.
Outcomes
Primary Outcome Measures
DAS-28 CRP
The change of Disease activity score in Rheumatoid arthritis patients
DAS-28 ESR
The change of Disease activity score in Rheumatoid arthritis patients
Secondary Outcome Measures
Full Information
NCT ID
NCT05665985
First Posted
November 26, 2022
Last Updated
December 17, 2022
Sponsor
Universitas Sebelas Maret
1. Study Identification
Unique Protocol Identification Number
NCT05665985
Brief Title
Effect Of Moringa Leaf Extract On Disease Activity In Rheumatoid Arthritis Patients
Official Title
Effect Of Moringa Leaf Extract On Disease Activity In Rheumatoid Arthritis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
July 30, 2020 (Actual)
Study Completion Date
September 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitas Sebelas Maret
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Intervention therapy study of moringa oliefera extract on the degree of activity of rheumatoid arthritis patients. The research subjects were patients with rheumatoid arthritis-intervention with moringa oliefera for 30 days.
Detailed Description
Rheumatoid arthritis is a progressive autoimmune disease. Delay in therapy and delay in remission will result in disability. This study is a randomized clinical trial using a new drug for rheumatoid arthritis, moringa oliefera. The choice of moringa oliefera was due to the ability of moringa oliefera in anti-inflammatory and immunosuppressant terms. This drug has also been proven in experimental studies on rheumatoid arthritis animals. This study with 30 research samples divided into two groups, containing 15 samples each for the treatment group and 15 for the control group. The treatment group was given Moringa oleifera extract of 40.50 mg/KGBW/day, while the control group was given a placebo for 30 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
This study was a Randomized Controlled Trial (RCT) with 30 research samples divided into two groups, containing 15 samples each for the treatment group and 15 for the control group. The treatment group was given Moringa oleifera extract of 40.50 mg/KGBW/day, while the control group was given a placebo for 30 days. The degree of disease activity (DAS28-CRP, DAS28-LED) was assessed before and after the intervention. Intervention with Dry Extract of Moringa Oleifera (trade name is Keloreena Ⓡ , registered number in National Food and Drug Registry: 193332021) The dose given is 1000 mg bi in day for 30 days. Inclusion criteria are Female patients, 18-60 years, who met the RA criteria according to the ACR / EULAR 2010 and VAS> 3. Exclusion criteria are Pregnant, using Methylprednisolone> 8 mg per day, using NSAIDs, and having comorbidities
Masking
ParticipantInvestigator
Masking Description
The capsule form between the drug and the placebo was the same, there was no drug name label on the drug packaging, and only a number was given on the drug packaging.
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Moringa Oliefera
Arm Type
Experimental
Arm Description
Intervention with Dry Extract of Moringa Oleifera (trade name is Keloreena Ⓡ , registered number in National Food and Drug Registry: 193332021) The dose given is 1000 mg bi in day for 30 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Capsules similar to moringa oliefera, which contain powder, have no pharmacological effect.
Intervention Type
Drug
Intervention Name(s)
Moringa Oleifera
Intervention Description
Intervention with Dry Extract of Moringa Oleifera (trade name is Keloreena Ⓡ , registered number in National Food and Drug Registry: 193332021) The dose given is 1000 mg bi in day for 30 days.
Primary Outcome Measure Information:
Title
DAS-28 CRP
Description
The change of Disease activity score in Rheumatoid arthritis patients
Time Frame
pre and post intervention (30 day)
Title
DAS-28 ESR
Description
The change of Disease activity score in Rheumatoid arthritis patients
Time Frame
pre and post intervention (30 day)
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of RA criteria according to the ACR / EULAR 2010
Visual analog score of more than three.
Exclusion Criteria:
Pregnancy
Using Methylprednisolone> 8 mg per day
Using NSAIDs
Chronic Kidney Disease
Diabetes Mellitus
Heart Failure
Lever disease
Facility Information:
Facility Name
RS UNS (Universitas Sebelas Maret Hospital)
City
Surakarta
State/Province
Central Java
ZIP/Postal Code
57145
Country
Indonesia
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect Of Moringa Leaf Extract On Disease Activity In Rheumatoid Arthritis Patients
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