Clinical research study on homeopathic medicine to evaluate effectiveness and safety on prevention of Infections.
- Registration Number
- CTRI/2023/12/060891
- Lead Sponsor
- Biosimilia Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1.Males and non-pregnant, non-lactating females between 18-65 years of age; inclusive at the time of signing the Informed Consent.
2.Willing and able to provide written informed consent prior to any study-specific procedures being performed.
3.Study participant is willing to be available for the entire study period and to adhere to protocol requirements as evidenced by signing informed consent document.
4.Study participants with no known history of E. coli or S. typhi or K. pneumonia or Hepatitis C infection 03 months prior to screening.
5.Judged by an investigator to be in good health as documented by the medical history, physical examination (including but may not be limited to an evaluation of the cardiovascular, gastrointestinal, respiratory, and central nervous systems), vital sign assessments, clinical laboratory assessments, and by general observations. Any abnormalities or deviations outside the normal ranges for any clinical testing (laboratory tests, vital signs) can be repeated at the discretion of the investigator(s) and judged to be not clinically significant for study participation.
6.Body mass index (BMI) between 18.5 kg/m2 to 24.9 kg/m2, inclusive for study participants calculated as (weight in kg) / (height in m)2 and weigh at least 50 kg.
7.Female participants of childbearing potential may be enrolled in the study if the participant fulfills all the following criteria:
-Has a negative pregnancy test at screening and on the day of randomization (Day 1).
-Is not currently breastfeeding.
•Has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to randomization (Day 1).
-Has agreed to continue adequate contraception through 3 months following the last dose.
Adequate female contraception is defined as consistent and correct use of a Food and Drug Administration (FDA) approved contraceptive method in accordance with the product label. For example: Barrier method (such as condoms, diaphragm, or cervical cap) used in conjunction with spermicide; intrauterine device; prescription hormonal contraceptive taken or administered via oral (pill), transdermal (patch), subdermal, or IM route; sterilization of a female participant’s monogamous male partner prior to entry into the study.
[Note: periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.]
1.Reports a history of allergic response(s) to the active ingredient or to any of the excipients of the Investigational homeopathic product.
2.Pregnant and Lactating Female.
3.Prior administration of E. coli or S. typhi or K. pneumonia or Hepatitis C vaccine or current/planned simultaneous participation in another interventional study.
4. Reports receiving any investigational drug within 90 days prior to randomization.
5.Demonstrates, in the opinion of study staff, veins unsuitable for repeated venipuncture (e.g., veins difficult to locate, access, or puncture; veins with a tendency to rupture during or after puncture).
6.Positive test results for E. coli or S. typhi or K. pneumonia or Hepatitis C antibodies.
7.Study participants had a known history of allergies or food hypersensitivity.
8.Unable to understand aims and constraints of study and complete self-evaluation study participant diary.
9. Other conditions, which in the opinion of the investigators make the study participants unsuitable for enrolment or could interfere with adherence to the study protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Measurement of levels / presence or absence of antibodies in serum samples obtained from the study participants after administration of E coli, S typhi, K pneumonia, and Hepatitis C nosodes.Timepoint: Screening, week 2 (± 3 days), week 4 (± 3 days- booster dose), week 6 (± 3 days), and week 8 (end of treatment).
- Secondary Outcome Measures
Name Time Method The proportion of study participants reporting incidences of AE & or SAE during the study & their assessment with respect to intensity, duration, pattern, & causal relationship to the study medication. <br/ ><br>Changes in Laboratory Safety Parameters Hematology & Serum Biochemistry analysis from baseline to end of the study. <br/ ><br>Timepoint: Screening, Baseline, week 2, week 4,week 6,and week 8.