A Safety and Efficacy of Homeopathic Medicine Rhus Toxicodendron 30 in the Treatment of Rheumatoid Arthritis

August 1, 2013 updated by: ravinder kochhar, Healthcare Homoeo Charitable Society

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • India
      • Delhi, India
        • Recruiting
        • Gupta Homoeo Clinic
        • Contact:
        • Sub-Investigator:
          • mohit gupta, B.H.M.S
        • Sub-Investigator:
          • bhuwnesh goyal, B.A.M.S
        • Sub-Investigator:
          • prateek singh, B.H.M.S
    • Punjab
      • Ludhiana, Punjab, India, 141001
        • Recruiting
        • Kochhar Clinic
        • Contact:
        • Contact:
        • Sub-Investigator:
          • seenia sharma, B.H.M.S
        • Sub-Investigator:
          • kuljinder kaur, B.H.M.S

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: placebo
1/2 ml of dispensing alcohol administered orally at every 7 day for 5 month .
Drug: placebo
1/2 ml of dispensing alcohol is administered every 7 day for 5 month orally.
Other Names:
  • dispensing alcohol
Active Comparator: Rhustoxicodendron 30
1/2ml Rhustoxicodendron 30 is administered orally every 7 day for 5 month.
Drug: Rhustoxicodendron 30
1/2ml Rhustoxicodendron 30 is administered orally every 7 day for 5 month.
Other Names:
  • poison ivy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
6 weeks upto 24 week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
mean change from baseline in tender joint count.
Time Frame: 6 weeks upto 24 week
6 weeks upto 24 week
mean change from baseline in swollen joint.
Time Frame: 6 weeks upto 24 week
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 physician assessment of disease activity via visual analog scale(0-100 mm)
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 patient global assessment of disease via visual analog scale(0-100 mm)
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
6 weeks upto 24 week
mean change from baseline in ESR
Time Frame: 6 weeks upto 24 week
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
6 weeks upto 24 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Healthcare Homoeo Charitable Society

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: ravinder kochhar, MD hom, Healthcare Homoeo Charitable Society
  • Study Director: mukesh k singh, B.H.M.S, health care homoeo charitable society

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2013

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2014

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 19, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 23, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 2, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SLSGB-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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