Effect Of Moringa Leaf Extract On Disease Activity In Rheumatoid Arthritis Patients
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Universitas Sebelas Maret
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- DAS-28 ESR
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
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.
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Moringa Oliefera
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.
Intervention: Moringa Oleifera (Drug)
Placebo
Capsules similar to moringa oliefera, which contain powder, have no pharmacological effect.
Intervention: Moringa Oleifera (Drug)
Outcomes
Primary Outcomes
DAS-28 ESR
Time Frame: pre and post intervention (30 day)
The change of Disease activity score in Rheumatoid arthritis patients
DAS-28 CRP
Time Frame: pre and post intervention (30 day)
The change of Disease activity score in Rheumatoid arthritis patients
Secondary Outcomes
No secondary outcomes reported
Investigators
Nurhasan Agung Prabowo
Head of Hospital Research Unit
Universitas Sebelas Maret