CTRI/2022/02/040107
Completed
未知
An open label study to evaluate the safety and tolerability of turmeric-boswellia formulation in healthy adult volunteers
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Arjuna Natural Private Limited
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Males or Females above 18 and below 55 years of age.
- •2\. Volunteer must be able, willing and likely to fully comply with study procedures and restrictions.
- •3\. No clinically significant abnormalities judged by the principal investigator based on the medical history, physical examination, electrocardiogram, chest X\-ray, and routine laboratory evaluations.
- •4\. Individuals who have been tested negative for SARS\-COV2 in a RT\-PCR test.
- •5\. Voluntariness to participate in the trial and give signed informed consent.
Exclusion Criteria
- •1\. Individuals who have been tested positive to be infected with SARS\-COV2 in a RT\-PCR test.
- •2\. Patients with history of co\-morbid illnesses such as cardiovascular, endocrine, renal, hepatic or other chronic disease likely to affect stress/anxiety or limit normal function.
- •3\. Individuals with history of serious complications of diseases such as cancer, heart disease, infraction, stroke, arterial fibrillation, cardiac arrhythmia, disabilities, neurodegenerative disease.
- •4\. Subjects with alcohol and/or substance dependence.
- •5\. Subjects with known allergic reactions to test drug or any of its ingredients or any other herbal supplements.
- •6\. Undergone surgery during last one year.
- •7\. Individuals participating in any other clinical trial.
- •8\. Female volunteers who are found positive in Urinary Pregnancy Test or are lactating.
- •9\. Any condition, including laboratory abnormalities, that in the opinion of investigator places the volunteer at an unacceptable risk or deems the volunteer not suitable for participation in the study.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Not Applicable
To study the safety of Ashwagandha extract in healthy peopleCTRI/2022/08/044636Arjuna Natural Private Limited62
Active, not recruiting
Phase 1
A study to evaluate the safety of REN001 capsules when given for 12 weeks (with option to continue treatment) to patients with mitochondrial myopathies.EUCTR2018-002969-19-GBReneo Pharma Ltd.24
Recruiting
Phase 2
A study to investigate the safety and feasibility of delivering MDMA-assisted psychotherapy to patients with posttraumatic stress disorderPosttraumatic Stress DisorderMental Health - Other mental health disordersACTRN12623000838617Emyria Ltd5
Completed
Not Applicable
An open label study to assess the safety and tolerability of PB006 administered as a single intravenous infusioNL-OMON48246bioeq GmbH10
Unknown
Phase 2
A Clinical Study to evaluate the Safety and Efficacy of LP011-09 in subjects with Allergic RhinitisHealth Condition 1: null- Positive history of Allergic Rhinitis as judged by the InvestigatorCTRI/2012/03/002473aila Pharmaceutical Pvt Ltd40