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NCT Number: NCT05665985

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

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

RS UNS (Universitas Sebelas Maret Hospital)

Surakarta, Central Java, 57145, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Moringa Oleifera

Drug

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 outcomes

  1. DAS-28 CRP

    Time frame: pre and post intervention (30 day)

    The change of Disease activity score in Rheumatoid arthritis patients

  2. DAS-28 ESR

    Time frame: pre and post intervention (30 day)

    The change of Disease activity score in Rheumatoid arthritis patients

Sponsors and collaborators

Lead sponsor

Universitas Sebelas Maret

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 27, 2022
Registry last updated
Dec 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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