Effect Of Moringa Leaf Extract On Disease Activity In Rheumatoid Arthritis Patients

Phase 1

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Moringa Oleifera

• Registration Number: NCT05665985
• Lead Sponsor: Universitas Sebelas Maret

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 Timeline

• Study Start: 2020-05-01
• Primary Completion: 2020-07-30
• Study Completion: 2020-09-30
• Study First Submitted: 2022-11-26
• Status Verified: 2022-12
• Study First Submitted QC: 2022-12-17
• Last Update Submitted: 2022-12-17
• Study First Posted: 2022-12-27
• Last Update Posted: 2022-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Moringa Oliefera	Moringa Oleifera	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.
Placebo	Moringa Oleifera	Capsules similar to moringa oliefera, which contain powder, have no pharmacological effect.

Primary Outcome Measures

Name	Time	Method
DAS-28 ESR	pre and post intervention (30 day)	The change of Disease activity score in Rheumatoid arthritis patients
DAS-28 CRP	pre and post intervention (30 day)	The change of Disease activity score in Rheumatoid arthritis patients

Trial Locations

Locations (1)

RS UNS (Universitas Sebelas Maret Hospital); 🇮🇩 Surakarta, Central Java, Indonesia