Prospective Single Arm Open Clinical Trial To Study The Efficacy Of Polyherbal Combination A K Vati In Anidra With Special Reference To Stress Induced Insomnia
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
Study Overview
Brief Summary
This current clinical trial is Single arm open clinical trial
This study is being conducted to evaluate the efficacy of polyherbal combination A. K. Vati in management of Anidra with special reference to Stress Induced Insomnia
After screening the patients at OPD and IPD level 60 patients will be selected for trial, informed written consent will be taken in native language
Insomnia (Inadequate quality and quantity of sleep) may be a symptom of stressful lifestyle, depressive illness, anxiety disorders, any psychiatric conditions or any other pathologic conditions. Whatever may be the cause of insomnia it needs immediate attention in present day lifestyle. It is affecting nearly 1/3rd of population (especially youth) in western developed countries and the incidence are increasing day by day in the developing countries like India, Nepal, Sri Lanka, Bangladesh etc. If insomnia is left untreated, it may reduce mental capacity of an individual, reduce efficacy, increase the chances of various types of accident and ultimately it may drag the individual towards several severe psychosomatic disorders.
Null Hypothesis
A. K. Vati 1000 mg orally at bedtime for 21 Days is not effective in Anidra with special reference to Stress Induced Insomnia
Alternative Hypothesis
A. K.Vati 1000 mg orally at bedtime for 21 Days is effective in Anidra with special reference to Stress Induced Insomnia
Drug - Polyherbal combination A.K. Vati
Dose - 1000 mg at bedtime
Anupana - Koshna Dugdha
Sevana Kala - At bedtime
Duration - 21 Days
Follow up - 7th , 14 th and 21st Day
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Individuals between the age group of 18 to 80 years of both sexes having stress induced insomnia of minimum one month duration selected randomly for study patients of insomina with HTN depression and anxiety disorder without any complications of any othe diseases.
Exclusion Criteria
- •Patients below 18 years and above 80 years of age Patients with major psychiatric illness like schizophrenia depressive psychosis epilepsy etc were not registered.
- •Patients having chronic illness like asthma malignancies liver cirrhosis chronic renal failure diabetes etc were excluded Patients with acute illness like cardiovascular accidents congestive cardiac failure myocardial infarction chronic obstructive pulmonary disorders meningitis acute pain conditions and similar other disorders were excluded.
Investigators
Dr Akanksha Dnyandeo Kadam
Sheth Chandanmal Mutha Aryangla Vaidyak Mahavidyalaya,Satara