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

Rheumatoid Arthritis. Clinical Trial

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 .

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01905735
• Other study ID #: SLSGB-01
• Status: Recruiting
• Phase: Phase 2
• First received: July 19, 2013
• Last updated: August 1, 2013
• Start date: August 2013
• Est. completion date: February 2014

Study information

• Verified date: August 2013
• Source: Healthcare Homoeo Charitable Society
• Contact: seenia sharma, B.H.M.S
• Phone: 0091-7837144332
• Email: drseeniasharma[@]gmail.com
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical 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.

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis.

Intervention

Drug:
• Rhustoxicodendron 30
1/2ml Rhustoxicodendron 30 is administered orally every 7 day for 5 month.
• placebo
1/2 ml of dispensing alcohol is administered every 7 day for 5 month orally.

Locations

Country	Name	City	State
India	Gupta Homoeo Clinic	Delhi
India	Kochhar Clinic	Ludhiana	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Healthcare Homoeo Charitable Society

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 weeks upto 24 week	No
Secondary	mean change from baseline in tender joint count.		6 weeks upto 24 week	No
Secondary	mean change from baseline in swollen joint.		6 weeks upto 24 week	No
Secondary	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)	every 6 weeks upto 24 week	No
Secondary	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)	6 weeks upto 24 week	No
Secondary	mean change from baseline in subject assessment of pain using VAS from 0-100 mm		6 weeks upto 24 week	No
Secondary	mean change from baseline in ESR		6 weeks upto 24 week	No
Secondary	mean change from baseline in disability index of the health assessment Questionnaire (HAQ)		6 weeks upto 24 week	No