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NCT05665985 Clinical Trial

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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05665985
Other study ID # NAP01
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date May 1, 2020
Est. completion date September 30, 2020

Study information
Verified date December 2022
Source Universitas Sebelas Maret
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date September 30, 2020
Est. primary completion date July 30, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 60 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• 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.

Locations
Country Name City State
Indonesia RS UNS (Universitas Sebelas Maret Hospital) Surakarta Central Java

Sponsors (1)
Lead Sponsor Collaborator
Universitas Sebelas Maret

Country where clinical trial is conducted

Indonesia, 

Outcome
Type Measure Description Time frame Safety issue
Primary DAS-28 CRP The change of Disease activity score in Rheumatoid arthritis patients pre and post intervention (30 day)
Primary DAS-28 ESR The change of Disease activity score in Rheumatoid arthritis patients pre and post intervention (30 day)
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