Clinical evaluation of A comprehensive Ayurvedic intervention in Manodwega (Generalized Anxiety Disorder)
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Primary Outcome Measure
Study Overview
Brief Summary
This study is a randomized parallel group clinical trial assessing the efficacy of Ashwagandha (Withania Somnifera) and Mandukaparni (Bacopa Monerii) in 3gm dose per day (1.5gm BID) in group I, and along with these medicines Shirodhara (Pouring of medicated herbal oil on the forehead for 30 minutes ) with Ksheerabala taila in Group II. The intervention period for internal medicines is 12 weeks in both the groups and Shirodhara in Group II will be during first 7 days. The study centre is Advanced centre for Ayurveda in Mental health and neurosciences, NIMHANS campus Bangalore. The primary objective is assessment of the safety and efficacy of intervention in terms of changes in HRS for Anxiety in Manodwega (GAD patients). Shirodhara is an Ayurvedic treatment procedure in which medicated oils are poured in a stream on the fore head for a period of 30 minutes. It is having effects like improving concentration, induces sleep and has a tranquilizing effect.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Open Label
Eligibility Criteria
- Ages
- 18.00 Year(s) to 45.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Age between 18 to 45 years of either sex 2.Diagnosed Cases of GAD Based on DSM IV diagnostic criteria for Generalized Anxiety Disorder 3.Willing to give written informed consent for the participation.
Exclusion Criteria
- •1.Age less than 18 years and more than 45 years.
- •2.Depression 3.Social phobias 4.Hypertension 5.Cardiac diseases 6.Epilepsy 7.Asthma and COPD 8.Hyperthyroidism 9.Diabetes 10.Alcoholics and Drug addicts.
Outcomes
Primary Outcomes
Primary Outcome Measure
Time Frame: Periodically once in 4 weeks till 12 weeks duration
To assess improvement in total Hamilton anxiety rating scale
Time Frame: Periodically once in 4 weeks till 12 weeks duration
Secondary Outcomes
- Secondary Outcome Measure(To observe change in individual components of Hamilton anxiety rating scale)