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

Sponsor
Universitas Sebelas Maret (Other)
Overall Status
Completed
CT.gov ID
NCT05665985
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
5
Actual Duration (Months)
6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Moringa Oleifera
 Phase 1/Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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 comorbiditiesThis 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
Masking:
Double (Participant, Investigator)
Masking Description:
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.
Primary Purpose:
Treatment
Official Title:
Effect Of Moringa Leaf Extract On Disease Activity In Rheumatoid Arthritis Patients
Actual Study Start Date :
May 1, 2020
Actual Primary Completion Date :
Jul 30, 2020
Actual Study Completion Date :
Sep 30, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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.
Placebo Comparator: Placebo

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

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.

Outcome Measures

Primary Outcome Measures

  1. DAS-28 CRP [pre and post intervention (30 day)]

    The change of Disease activity score in Rheumatoid arthritis patients

  2. DAS-28 ESR [pre and post intervention (30 day)]

    The change of Disease activity score in Rheumatoid arthritis patients

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 RS UNS (Universitas Sebelas Maret Hospital) Surakarta Central Java Indonesia 57145

Sponsors and Collaborators

  • Universitas Sebelas Maret

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nurhasan Agung Prabowo, Head of Hospital Research Unit, Universitas Sebelas Maret
ClinicalTrials.gov Identifier:
NCT05665985
Other Study ID Numbers:
  • NAP01
First Posted:
Dec 27, 2022
Last Update Posted:
Dec 27, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid

Study Results

No Results Posted as of Dec 27, 2022