Rheumatoid Arthritis
Conditions
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.
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.
Interventions
DRUGMoringa 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.
Sponsors
Universitas Sebelas Maret
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, 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.
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 comorbidities
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DAS-28 CRP | pre and post intervention (30 day) | The change of Disease activity score in Rheumatoid arthritis patients |
| DAS-28 ESR | pre and post intervention (30 day) | The change of Disease activity score in Rheumatoid arthritis patients |
Countries
Indonesia
Outcome results
None listed