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A Clinical Study to Evaluate the Safety and Efficacy of Divyaratan oil in patients with Headache, Mental Tension and Fatigue.

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. - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/06/054469
Enrollment
30
Registered
2023-06-27
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

Aryanveda Cosmeceuticals
Lead Sponsor

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

MeasureTime 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

MeasureTime 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

Public ContactSunita C

Aryanveda Cosmoceuticals

vijaykimtata.vk@gmail.com9816333352

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026