Rheumatoid ArthritisPhase 1/2NCT05665985
Effect Of Moringa Leaf Extract On Disease Activity In Rheumatoid Arthritis Patients
A Phase 1/2 study testing Moringa Oleifera in people with Rheumatoid Arthritis, run by Universitas Sebelas Maret at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Moringa Oleifera
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 May 2020to 30 Sep 2020
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of RA criteria according to the ACR / EULAR 2010
- Visual analog score of more than three.
Who cannot join
- Pregnancy
- Using Methylprednisolone> 8 mg per day
- Using NSAIDs
- Chronic Kidney Disease
- Diabetes Mellitus
- Heart Failure
- Lever disease
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
RS UNS (Universitas Sebelas Maret Hospital)
Surakarta, Central Java, 57145
About this study
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.
Read the 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Moringa Oleifera
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moringa OleiferaDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Moringa Oleifera |
| Placebo | Placebo comparator | Capsules similar to moringa oliefera, which contain powder, have no pharmacological effect. Receives: Drug: Moringa Oleifera |
What is being measured
The primary outcome is the main question the study is designed to answer.
DAS-28 CRP
The change of Disease activity score in Rheumatoid arthritis patients
Measured: pre and post intervention (30 day)
DAS-28 ESR
The change of Disease activity score in Rheumatoid arthritis patients
Measured: pre and post intervention (30 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start1 May 2020
- Primary completion30 Jul 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Sebelas Maret
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurhasan Agung Prabowo, Universitas Sebelas Maret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05665985
- Sponsor's protocol ID
- NAP01
- Status last verified
- Dec 2022
- First submitted
- 26 Nov 2022
- Last updated
- 27 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Moringa Leaf Extract On Disease Activity In Rheumatoid Arthritis Patients
- ClinicalTrials.gov ID
- NCT05665985
- Acronym / sponsor ID
- NAP01
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universitas Sebelas MaretUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 27 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Moringa Oliefera | Experimental | Drug: Moringa OleiferaIntervention 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 | Placebo comparator | Drug: Moringa OleiferaCapsules similar to moringa oliefera, which contain powder, have no pharmacological effect. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Diagnosis of RA criteria according to the ACR / EULAR 2010
- Visual analog score of more than three.
Key exclusion criteria (7 listed)
- Pregnancy
- Using Methylprednisolone> 8 mg per day
- Using NSAIDs
- Chronic Kidney Disease
- Diabetes Mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moringa OleiferaIntervention 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 Oliefera, Placebo |
Primary outcome
DAS-28 CRP
Time frame: pre and post intervention (30 day)
The change of Disease activity score in Rheumatoid arthritis patients
DAS-28 ESR
Time frame: pre and post intervention (30 day)
The change of Disease activity score in Rheumatoid arthritis patients
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Moringa Oleifera in people with Rheumatoid Arthritis, run by Universitas Sebelas Maret at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DAS-28 CRP (time frame: pre and post intervention (30 day)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2022.