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

NCT05665985 | Completed Phase 1 DMC

• 1 other identifier: NAP01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

• DAS-28 CRP

  The change of Disease activity score in Rheumatoid arthritis patients

  pre and post intervention (30 day)

• DAS-28 ESR

  The change of Disease activity score in Rheumatoid arthritis patients

  pre and post intervention (30 day)

Study Arms (2)

Moringa Oliefera

EXPERIMENTAL

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.

Drug: Moringa Oleifera

Placebo

PLACEBO COMPARATOR

Capsules similar to moringa oliefera, which contain powder, have no pharmacological effect.

Drug: Moringa Oleifera

Interventions

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.

Moringa Oliefera; Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of RA criteria according to the ACR / EULAR 2010
• Visual analog score of more than three.

You may not qualify if:

• Pregnancy
• Using Methylprednisolone\> 8 mg per day
• Using NSAIDs
• Chronic Kidney Disease
• Diabetes Mellitus
• Heart Failure
• Lever disease

Sponsors & Collaborators

• Universitas Sebelas Maret: lead

Study Sites (1)

RS UNS (Universitas Sebelas Maret Hospital)

Surakarta, Central Java, 57145, Indonesia

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

flocculant protein MO 2.1, Moringa oleifera

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Hospital Research Unit

Model Details: 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

Study Record Dates

• First Submitted: November 26, 2022
• First Posted: December 27, 2022
• Study Start: May 1, 2020
• Primary Completion: July 30, 2020
• Study Completion: September 30, 2020
• Last Updated: December 27, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)