A Clinical Study to Evaluate the Safety and Efficacy of Divyaratan oil in patients with Headache, Mental Tension and Fatigue.
- Registration Number
- CTRI/2023/06/054469
- Lead Sponsor
- Aryanveda Cosmeceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
1. Subjects aged between 18 to 65 years.
2. Subjects suffering from mild to moderate anxiety (who achieve scores between 18 and 24
points on the Hamilton Scale for Anxiety).
3. Subjects of female gender or a non-pregnant, non-lactating female, at least six weeks
postpartum. A urine pregnancy test is required for all female subjects unless the subject has
had a hysterectomy or tubal ligation, or is > 2 years postmenopausal.
4. Subjects are willing to follow the procedures as per the study protocol and voluntarily sign
an informed consent form.
1. Subjects having addiction to any drug, including alcohol will not be recruited in the trial.
2. Subjects who are using any medication such as anxiolytic, anti-stress medication and
under psychotherapy will not be recruited in the trial.
3. Subjects having a chronic, contagious infectious disease, such as active tuberculosis,
Hepatitis B or C, or HIV.
4. Known hypersensitivity to ingredients used in the Investigational Product.
5. Pregnant and Lactating females.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method