A Clinical Study to Evaluate the Safety and Efficacy of Divyaratan oil in patients with Headache, Mental Tension and Fatigue.
Not Applicable
Completed
- Conditions
- Headache, mental tension and Fatigue
- Registration Number
- CTRI/2023/06/054469
- Lead Sponsor
- Aryanveda Cosmeceuticals
- Brief Summary
This study is a prospective, single arm, open label, single centre clinical study to evaluate the safety and efficacy of Divyaratan oil in reducing headache, mental tension and fatigue.
Primary Objective
• To evaluate the efficacy of the Divyaratan oil in reducing headache ,mental tension ,minor insomnia ,stress and mental tiredness.
Secondary Objective
• To evaluate the efficacy of the Divyaratan oil in reducing sun stroke/ heat stroke by external cooling.
• To evaluate the safety of the the Divyaratan oil.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- Subjects aged between 18 to 65 years.
- Subjects suffering from mild to moderate anxiety (who achieve scores between 18 and 24 points on the Hamilton Scale for Anxiety).
- 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.
- Subjects are willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form.
Exclusion Criteria
- Subjects having addiction to any drug, including alcohol will not be recruited in the trial.
- Subjects who are using any medication such as anxiolytic, anti-stress medication and under psychotherapy will not be recruited in the trial.
- Subjects having a chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
- Known hypersensitivity to ingredients used in the Investigational Product.
- Pregnant and Lactating females.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method • To test the Efficacy of the Divyaratan oil to reduce Headache, Tension, minor insomnia, stress & mental tiredness. Day 42 Assessment: Day 42 Subjective assessment questionnaire will be provided to the each subject, based on that the outcome will be assessed. Day 42
- Secondary Outcome Measures
Name Time Method • To test the Efficacy of the Divyaratan oil to reduce sun stroke by external cooling. • To evaluate the Safety of the product.
Trial Locations
- Locations (1)
Dr. Uday’s Advance Skin and Hair clinic
🇮🇳Bangalore, KARNATAKA, India
Dr. Uday’s Advance Skin and Hair clinic🇮🇳Bangalore, KARNATAKA, IndiaDr Uday KumarPrincipal investigator6364147989info@samahitha.com