MedDataX Logo

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

NCT ID: NCT05665985

Last Updated: 2022-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-01

Study Completion Date

2020-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rheumatoid Arthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Moringa Oleifera

Intervention Type 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.

Placebo

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

Group Type PLACEBO_COMPARATOR

Moringa Oleifera

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universitas Sebelas Maret

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Nurhasan Agung Prabowo

Head of Hospital Research Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

RS UNS (Universitas Sebelas Maret Hospital)

Surakarta, Central Java, Indonesia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Indonesia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NAP01

Identifier Type: -

Identifier Source: org_study_id