A comparative clinical study to evaluate the tranquilizing effect of yastimadhu ksheera paka and kushmanda rasayana granules in artists with social phobia.
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Assessment will be done by scoring subjective parameters by assessing on 0th, 14th and 28th day.
Overview
Brief Summary
This is Raandomised open labelled parallel group study comparing the safety and efficacy of the trial drug Group A – Yastimadhu Ksheera Paka1pala before food morning Group B – Kushmanda Rasayana Granules12grams with milk on empty stomach early morning for 28 days in each group and study will be conducted in Shri Dharmasthala Manjunatheshwara college of Ayurveda Kuthpady Udupi, Karnataka, India. The primary measures will be assessed through Severity Measure for Social Anxiety Disorder (Social Phobia). According to American psychiatric association, Hamilton’s Anxiety Rating Scale, Manasika bhava scale. The secondary outcome majors will be assessed based on the WHO Quality of life Scale-Brief hence the study is an effort to prove the efficacy of Yastimadhu Ksheera Paka and Kushmanda Rasayana Granules in artists with social phobia.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 30.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Subject fulfilling the DSM-5 Diagnostic criteria [for Social Phobia].
- •2.Artists – stage performers (Dancers, Singers, musician, debate, pick and speak, pick and act) 3.Age group: 18 -30yrs 4.Participants who are willing and able to provide informed consent.
Exclusion Criteria
- •Subjects suffering from any other psychiatric and any organic disorders, lactating and pregnant Women will be excluded.
Outcomes
Primary Outcomes
Assessment will be done by scoring subjective parameters by assessing on 0th, 14th and 28th day.
Time Frame: Observation will be done on 0th , 14th and 28th day
Severity Measure for Social Anxiety Disorder (Social Phobia). According to American psychiatric association.
Time Frame: Observation will be done on 0th , 14th and 28th day
Hamilton’s Anxiety Rating Scale.
Time Frame: Observation will be done on 0th , 14th and 28th day
WHO Quality of life Scale-Brief.
Time Frame: Observation will be done on 0th , 14th and 28th day
Manasika bhava scale
Time Frame: Observation will be done on 0th , 14th and 28th day
Scored parameters will be analysed statistically after the treatment. All the subjective parameters and scales will be assessed using Wilcoxon signed rank test within the groups and Mann-Whitney U test in between the groups.
Time Frame: Observation will be done on 0th , 14th and 28th day
Secondary Outcomes
- quality of life(0th and 28th day)
Investigators
Dr Shantala S Bharbhari
Shri Dharmashtala Manjunateshwara College of Ayurveda,Hospital and Research Centre, kuthpady Udupi