Homeopathy drug proving study to observe clinical symptoms of H-009 in healthy volunteers.
- Registration Number
- CTRI/2012/03/002506
- Lead Sponsor
- Homeopathy India Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 22
Healthy volunteer.
The person must be trustworthy, able and ready to express and
describe his experiences during the Proving.
The usual habits and conduct of life should be continued.
The person should not plan to begin medical or surgical treatments
like dentist, surgery or psychotherapy during the drug proving.
The person selected for proving must be in such a mental and legalstate so as to able to exercise fully his/her choice and written
consent should be obtained.
Whose ECG and X ray reports are within normal range limits.
Current medical treatments or Homeopathic drugs in the preliminary
observation period or during the Proving.
Consumption of prescribed drugs (including Homeopathic) in the
past four weeks.
Contraceptive pills in the past three months.
Surgical treatment within past two months.
Pregnancy, breast feeding
Persons suffering from allergic manifestations particularly pertaining
to respiratory system and skin should not be included in proving.
volunteers with history of diabetes, hypertension and hypothyroid
should not be included in proving
Volunteers who are drug addicts should not be included in proving
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Symptoms experienced by provers will be <br/ ><br>recorded.Timepoint: Symptoms experienced by provers will be recorded daily and will be analyzed at the end of 6 week period.
- Secondary Outcome Measures
Name Time Method Safety parameters - including blood <br/ ><br>investigations ECG and X ray.Timepoint: Pre( screening) and post ( after completion of 5 <br/ ><br>doses of proving substance)