A Single-Center, Prospective, Open Labeled, Phase IV Clinical Study to Evaluate Safety and Efficacy of MY V3 Immune Herbal Capsules in Healthy Participants.
- Registration Number
- CTRI/2024/05/067457
- Lead Sponsor
- Sidhva Herbal and Foods Pondicherry
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1) Male/females of greater than or equal to 18 years of age at the time of consent
2) Patient / Legally Acceptable Representative who can and willing to provide Informed Consent
3) Confirmed anemia
4) Clinically stable for at least 1 month prior to entry into the study
5) Score on the Insomnia Severity Index (ISI) measure greater than or equal to 15
1) Pregnant or lactating women or women of childbearing potential who did not use oral contraceptives or an intrauterine device
2) Administration of another investigational drug within 1 month before screening or planned during the study period
3) Patients who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol
4) Diagnosis of other primary sleep disorders
5) Psychotherapy within the past six months
6) Shift workers
7) Current or expected use of hypnotic medications
8) Renal or hepatic disease
9) History of Neurological disorder or cardiovascular disease raising safety concerns
10) Excessive coffee or cigarette use
11) Recent surgery
12) Current alcohol/substance use disorder
13) Current major depressive episode
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method