Health Condition 1: F411- Generalized anxiety disorder Health Condition 2: G- Mental Health
Conditions
Interventions
None listed
Sponsors
central council for Ayurvedic sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participants of >=25 years and 2. Cases of generalized anxiety disorder (GAD) as per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) and Hamilton Rating Scale for Anxiety (HAM-A) score between 8 & 23, at the time of screening. 3. Willing to provide informed written consent and to adhere to the treatment for a period of 90 days
Exclusion criteria
Exclusion criteria: 1. History of episode of major depressive disorder in the previous 6 months 2. History of regular use of anxiolytics or antidepressants in the previous 6 months 3. History of suicidal tendency, suicide attempt or self-injurious behavior in the past 12 months 4. Participants with alcohol or other drug use disorder (AUD) (CAGE score >2) 5. Known cases of uncontrolled Hypertension. (Average BP>= 160/100 mm of Hg), uncontrolled Diabetes mellitus (HbA1c > 8% or RBS>=200mg/dl), active thyroid dysfunction with or without medication [either S. TSH >10mIU/ml or 2 times of the upper normal limit), renal Dysfunction (defined as S. creatinine > 1.2 mg/dl) 6. History of serious cardiac dysfunction or Pulmonary Dysfunction (Asthmatic and COPD patients), any severe cognitive or any other psychotic illness needing treatiment (like mental retardation, dementia, amnesia, Schizophrenia, schizoaffective, etc.), bulimia or anorexia nervosa, neurological disorders, hemorrhagic problems, coagulation, or bleeding issues within 90 days prior to the screening 7. Pregnant or lactating women 8. Participants with history of cancer or chronic inflammatory conditions including but not limited to chronic infection like tuberculosis, leprosy, HIV, and collagen vascular diseases 9. Participants on hormone replacement therapy, steroid therapy, chemotherapy or immunosuppressive therapy 10. Any other condition which PI would adversely affect the study/ study outcomes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Assessment of treatment adherence through self-reported compliance log and used medication containers/strips â?¢Assessment of the tolerability of Ayush SR through reported incidence of adverse events (GIT-related AE specifically) during the study period at 30th day, 60th day and 90th day. once in 30 days Timepoint: 1. Assessment of treatment adherence through self-reported compliance log and used medication containers/strips â?¢Assessment of the tolerability of Ayush SR through reported incidence of adverse events (GIT-related AE specifically) during the study period at every follow up i.e at 30th day, 60th day and 90th day. once in 30 days | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Number of participants with Hamilton Rating Scale for Anxiety (HAM-A) score â?¤7 at the end of treatment â?¢ Change in mean score of Hamilton Rating Scale for Anxiety (HAM-A) from Baseline [Time Frame: Baseline, 30th day, 60th day and 90th day] â?¢ Change in Pittsburg Sleep Qulaity Index Score from Baseline [Time Frame: Baseline, 30th day, 60th day and 90th day] â?¢ Change in Epworth Sleepiness Scale (ESS) from Baseline [Time Frame: Baseline, 30th day, 60th day and 90th day] â?¢ Change in Penn State Worry Questionnaire from Baseline [Time Frame: Baseline, 30th day, 60th day and 90th day] â?¢ Change in the laboratory safety parameters from baseline (CBC, LFT, KFT) (Time frame: baseline, and 90th day) â?¢ Any change in hematological parameters viz., Red Blood Cell count, Red cell distribution width (RDW), Platelet Count, Platelet distribution width (PDW), and Mean platelet volume (MPV); and levels of inflammatory markers viz., CRP [Time Frame: Baseline and 90th day] Timepoint: Study Duration: 2 years Timeline: Preparatory period: 02 months (for Recruitment of research staff, CTRI registration, Preparation of CRF & e-Format, Training of research team, Procurement of Medicines) Study intervention (for each participant): 3 months Follow-up: Nil Participant recruitment period: 16 months Statistical analysis & report writing: 03 months ;efficacy and adherence to Ayush SR tabletsTimepoint: 0 30 60 90 | — |
Countries
India
Contacts
Public ContactDr G V Ramana
Central Ayurveda research institute.
Outcome results
None listed