None listed
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • To test the Efficacy of the Divyaratan oil to reduce Headache, Tension, minor insomnia, stress & mental tiredness. Assessment: Subjective assessment questionnaire will be provided to the each subject, based on that the outcome will be assessed.Timepoint: Day 42 | — |
Secondary
| Measure | Time frame |
|---|---|
| • To test the Efficacy of the Divyaratan oil to reduce sun stroke by external cooling. • To evaluate the Safety of the product. • Mean change in the in Hamilton Rating Scale for Anxiety from baseline visit to week 4. Assesment : Hamilton Rating Scale for Anxiety from baseline visit to week 4 will be performed. Timepoint: Week 4 | — |
Countries
India
Contacts
Aryanveda Cosmoceuticals