Rheumatoid Arthritis.Phase 2NCT01905735
A Safety and Efficacy of Homeopathic Medicine Rhus Toxicodendron 30 in the Treatment of Rheumatoid Arthritis
A Phase 2 study testing Rhustoxicodendron 30 in people with Rheumatoid Arthritis., run by Healthcare Homoeo Charitable Society at 2 sites in India.
Trial summary
the purpose of the study is to assess the safety and efficacy of commonly used Homeopathic medicine Rhustoxicodendron in 30 potency in the treatment of Rheumatoid arthritis. Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Rheumatoid Arthritis.
- What is being tested?
- Rhustoxicodendron 30
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesIndia
- Study dates
- Aug 2013to Feb 2014
- Phase
- Phase 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 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- those who will provide written consent to participate in the study
- patient willing to turn up for 7th day follow up
- patient who are willing and compliance to the study
- those who are between 25 to 60 years .
- patient who are willing and compliance to the study .
- ESR more then 28 mm.
Who cannot join
- Participating as a subject in any other clinical research study.
- Children below the age of 25years.
- Female subject who are pregnant or planning for pregnancy within 6 month.
- History of seizures
- Breast feeding women's.
- Patient on treatment for life threatening illness like cancer aids etc.
- Patient should not have any congenital abnormality or patient should not have undergone any operative procedure as consequences of RA.
Trial locations and contacts
2 sites in 1 country.
India2 sites, 2 recruiting
- Recruiting
Gupta Homoeo Clinic
Delhi, National Capital Territory of Delhi
mohit gupta, B.H.M.S, 0091-9212580805, dr.mohitgupta@yahoo.in
mohit gupta, B.H.M.S
- Recruiting
Kochhar Clinic
Ludhiana, Punjab, 141001
seenia sharma, B.H.M.S, 0091-7837144332, drseeniasharma@gmail.com
mukesh k singh, B.H.M.S, 0091-9463131239, drmukeshkrsingh@gmail.com
About this study
Official title: A Multicentric,Double-blind,Placebo Controlled,Phase-2 Study to Assess the Safety and Efficacy of Homeopathic Medicine Rhus Toxicodendron 30 in the Treatment of Rheumatoid Arthritis .
the purpose of the study is to assess the safety and efficacy of commonly used Homeopathic medicine Rhustoxicodendron in 30 potency in the treatment of Rheumatoid arthritis.
Read the detailed description
it is a multicenter phase 2 ,double blind study in patient with active Rheumatoid arthritis ,there are 2 group in the study A and B ,where group A receive Rhustoxicodendron in 30 potency the first dose will administered orally (1/2 ml)after the completion of case taking ,and repeated every 7th day for 5 month and on the other hand group B receive placebo orally in (1/2 ml) at same interval for same period .
- Conditions
- Rheumatoid Arthritis.
- Being tested
- Rhustoxicodendron 30, placebo
- Keywords
- RA
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhustoxicodendron 30Drug
Also called poison ivy
1/2ml Rhustoxicodendron 30 is administered orally every 7 day for 5 month.
placeboDrug
Also called dispensing alcohol
1/2 ml of dispensing alcohol is administered every 7 day for 5 month orally.
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | 1/2 ml of dispensing alcohol administered orally at every 7 day for 5 month . Receives: Drug: placebo |
| Rhustoxicodendron 30 | Active comparator | 1/2ml Rhustoxicodendron 30 is administered orally every 7 day for 5 month. Receives: Drug: Rhustoxicodendron 30 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subject With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders).
number of subject with ACR criteria improvement consisting of ACR 20,ACR50,ACR70 reduction in tender and swollen joint counts and 20%,50%,70% improvement respectively in 3 of the following 5 criteria .
- physician global assessment of disease activity's.
- patient global assessment of disease activity's.
- subject assessment of pain
- subject assessment of function disability via health assessment questionnaire[HAQ]
- acute phase reactant ESR every 6 weeks upto 24 week
Measured: 6 weeks upto 24 week
Secondary outcomes (7)
mean change from baseline in tender joint count.
Measured: 6 weeks upto 24 week
mean change from baseline in swollen joint.
Measured: 6 weeks upto 24 week
mean change from baseline in physician global assessment of disease activity.
mean change from baseline in physician assessment of disease activity via visual analog scale(0-100 mm)
Measured: every 6 weeks upto 24 week
mean change from baseline in patient global assessment of disease .
mean change from baseline in patient global assessment of disease via visual analog scale(0-100 mm)
Measured: 6 weeks upto 24 week
mean change from baseline in subject assessment of pain using VAS from 0-100 mm
Measured: 6 weeks upto 24 week
mean change from baseline in ESR
Measured: 6 weeks upto 24 week
mean change from baseline in disability index of the health assessment Questionnaire (HAQ)
Measured: 6 weeks upto 24 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2013 (estimated)
- Study startAug 2013
- Primary completionJan 2014 (estimated)
- Study completionFeb 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis.Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Healthcare Homoeo Charitable Society
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ravinder kochhar, Healthcare Homoeo Charitable Society
- Investigators
- ravinder kochhar, MD hom, Principal investigator, Healthcare Homoeo Charitable Societymukesh k singh, B.H.M.S, Study director, health care homoeo charitable society
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01905735
- Sponsor's protocol ID
- SLSGB-01
- Status last verified
- Aug 2013
- First submitted
- 19 Jul 2013
- Last updated
- 2 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentric,Double-blind,Placebo Controlled,Phase-2 Study to Assess the Safety and Efficacy of Homeopathic Medicine Rhus Toxicodendron 30 in the Treatment of Rheumatoid Arthritis .
- ClinicalTrials.gov ID
- NCT01905735
- Acronym / sponsor ID
- SLSGB-01
- Conditions
- Rheumatoid Arthritis.
- Keywords
- RA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Healthcare Homoeo Charitable SocietyUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Feb 2014 (estimated)
- First posted
- 23 Jul 2013 (estimated)
- 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.
the purpose of the study is to assess the safety and efficacy of commonly used Homeopathic medicine Rhustoxicodendron in 30 potency in the treatment of Rheumatoid arthritis.
Detailed description
it is a multicenter phase 2 ,double blind study in patient with active Rheumatoid arthritis ,there are 2 group in the study A and B ,where group A receive Rhustoxicodendron in 30 potency the first dose will administered orally (1/2 ml)after the completion of case taking ,and repeated every 7th day for 5 month and on the other hand group B receive placebo orally in (1/2 ml) at same interval for same period .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: placebo1/2 ml of dispensing alcohol administered orally at every 7 day for 5 month . |
| Rhustoxicodendron 30 | Active comparator | Drug: Rhustoxicodendron 301/2ml Rhustoxicodendron 30 is administered orally every 7 day for 5 month. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- those who will provide written consent to participate in the study
- patient willing to turn up for 7th day follow up
- patient who are willing and compliance to the study
- those who are between 25 to 60 years .
- patient who are willing and compliance to the study .
Key exclusion criteria (7 listed)
- Participating as a subject in any other clinical research study.
- Children below the age of 25years.
- Female subject who are pregnant or planning for pregnancy within 6 month.
- History of seizures
- Breast feeding women's.
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 |
|---|---|---|
| Rhustoxicodendron 30Also: poison ivy1/2ml Rhustoxicodendron 30 is administered orally every 7 day for 5 month. | Drug | Rhustoxicodendron 30 |
| placeboAlso: dispensing alcohol1/2 ml of dispensing alcohol is administered every 7 day for 5 month orally. | Drug | placebo |
Primary outcome
Number of subject With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders).
Time frame: 6 weeks upto 24 week
number of subject with ACR criteria improvement consisting of ACR 20,ACR50,ACR70 reduction in tender and swollen joint counts and 20%,50%,70% improvement respectively in 3 of the following 5 criteria . 1. physician global assessment of disease activity's. 2. patient global assessment of disease activity's. 3. subject assessment of pain 4. subject assessment of function disability via health assessment questionnaire[HAQ] 5. acute phase reactant ESR every 6 weeks upto 24 week
7 secondary outcomes
mean change from baseline in tender joint count.
Time frame: 6 weeks upto 24 week
mean change from baseline in swollen joint.
Time frame: 6 weeks upto 24 week
mean change from baseline in physician global assessment of disease activity.
Time frame: every 6 weeks upto 24 week
mean change from baseline in patient global assessment of disease .
Time frame: 6 weeks upto 24 week
mean change from baseline in subject assessment of pain using VAS from 0-100 mm
Time frame: 6 weeks upto 24 week
mean change from baseline in ESR
Time frame: 6 weeks upto 24 week
mean change from baseline in disability index of the health assessment Questionnaire (HAQ)
Time frame: 6 weeks upto 24 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2013.
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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.
ravinder kochhar, MD hom principal investigator
Healthcare Homoeo Charitable Society
mukesh k singh, B.H.M.S study director
health care homoeo charitable society
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rhustoxicodendron 30 in people with Rheumatoid Arthritis., run by Healthcare Homoeo Charitable Society at 2 sites in India.
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 6 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: status not confirmed, as of the sponsor's last update on 2 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. 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 phase mean?
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact seenia sharma, B.H.M.S (0091-7837144332, drseeniasharma@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subject With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders). (time frame: 6 weeks upto 24 week). 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 2 Aug 2013.