Homoeopathic drug proving: Randomized double blind placebo controlled trial for drug code 123
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 46
- Locations
- 3
- Primary Endpoint
- Pathogenesis of Drug Code 123
Study Overview
Brief Summary
The study is a double blind randomized placebo control clinical trial to see the pathogenetic effect of the investigational drug substance on healthy volunteers. The drug has proved in ascending potencies. The drug was administered after PME and 1 week run –in –period. The provers are advised to take 4 doses in a day (4 hourly) for 3 days from the prescribed batch of the coded drug. After the completion of the batch, one month washout period will be maintained in all provers, before the next batch is initiated. The codes will be broken after the completion of the study and data will be compiled to know the pathogenesis of this drug substance and analysed to find characteristic symptom (prescribing indication). The proving symptoms will be identified and segregated from the symptoms produced in placebo group. The proving symptoms will form the drug pathogenesis.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Healthy individuals with no apparent disease and normal routine laboratory parameters during screening 2.Healthy individuals identified as fit for proving by experts 3.Intelligent enough to record carefully the facts, subjective and objective symptoms generated by the IPS during proving.
- •4.Able to be informed of the nature of the study and willing to give written informed consent.
Exclusion Criteria
- •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.Persons with colour blindness.
- •3.Persons who have undergone surgery in last two months.
- •4.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, homoeopathic, naturopathic, unani, etc.) for any acute or chronic disease.
- •6.Participant must not be on any homoeopathic 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 and women who have undergone hysterectomy.
- •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.
Outcomes
Primary Outcomes
Pathogenesis of Drug Code 123
Time Frame: Approximately one year
Secondary Outcomes
No secondary outcomes reported