To find out the pathogenetic effects of BSC-022 on healthy volunteers.
- Registration Number
- CTRI/2022/06/043392
- Lead Sponsor
- Dr Rajesh Shah
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
1. Healthy individuals with no apparent disease and normal routine laboratory parameters during screening.
2. Intelligent enough to carefully record the facts, subjective and objective symptoms generated by the drug during proving.
3. Able to be informed of the nature of the study and willing to give written informed consent.
1. Any disease or condition which might compromise the hematopoietic, renal, endocrine, pulmonary, central nervous system, cardiovascular, immunological, dermatological, gastro-intestinal or any other body system.
2. COVID 19 RT-PCR positive individuals.
3. Persons with color blindness.
4. Persons who have undergone surgery in last two months, planned medical / dental treatment during the proving period including herbal or dietary supplements, procedures, or medications that are likely to interfere with, or substantially alter, responsiveness to the proving substance.
5. Volunteers on regular medication (allopathic, ayurvedic, Homeopathic, naturopathic, unani, etc.) for any acute or chronic disease.
6. Participant must not be on any Homeopathic remedy in the preceding one month and have had no significant change in health status in last one month.
7. Emotionally disturbed, hysterical, or anxious persons.
8. Persons having known history of allergies, food hypersensitivity, etc.
9. Women during pregnancy, puerperium and while breast-feeding.
10. Smokers who smoke more than 10 cigarettes per day.
11. Recent history of alcoholism / drug addictions or unlikely to refrain from excessive alcohol consumption / drug intake during the study period.
12. Participation in another clinical or proving trial during the last 6 months.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Symptoms experienced by provers will be recorded.Timepoint: Symptoms experienced by provers will be recorded daily for 7 weeks.
- Secondary Outcome Measures
Name Time Method Safety parameters - including blood investigations ECG and X rayTimepoint: Disappearance of symptoms which appeared during the proving and subsequent symptom (significant symptoms) free period of 15 days.