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An Ayurvedic formulation to manage the sleeplessness in old age population

Phase 2
Completed
Conditions
Insomnia. Ayurveda Condition: NIDRANASAH/ASVAPNAH,
Registration Number
CTRI/2022/11/047028
Lead Sponsor
Dr Omkar Devidas Ingale
Brief Summary

Nidra (Sleep) being one of the Trayopastambhas mentioned in Ayurveda; has uttermost importance in leading healthy & satisfactory life. It is a universal behavior seen among all the higher living things and occupies about 1/3rd of human lives. It helps to maintain nutritional balance, energy, reproductive health, senses orientation and psychosomatic as well as spiritual wellbeing. Proper sleep gives Sukh (happiness), Pushti (nourishment), Bala (strength), Vrishyata (aphrodisiac), Dnyaana (knowledge), Jeevita (life); While Improper sleep or less sleep results into Dukha (unhappiness), Karshyata (emaciation), Abala (weakness), Kleebata (impotant), Adnyaana (impaired knowledge or unwise), destroys the life. So, most essential thing for survival. Among all sleep disorders (7 amongst 81 are major as per ICSD-3), Insomnia is a common and universal complaint being present in about 25-30% of the population in general; also, In the studies by Suri et al insomnia increased progressively with age being 17.3%, 28.1% & 59.0% respectively in the child, adult & elderly population respectively. Existing Indian studies of insomnia among elderly subjects are few and utilize differing samples, with reported prevalence ranging from 20% to 59%. Women are affected more commonly than men, and it increases in both sexes with age. The WHO estimates that between 2015 and 2050, the proportion of the world’s population over 60 years will nearly double from 900 million to 2 billion (12% to 22%). India has thus acquired the label of an ageing nation with 7.7% of its population being more than 60 years old. It has long been the belief that the amount of the sleep needed per night decrease with age and insomnia is a normal phenomenon with older age. But many studies have confirmed that, need for sleep may not changes with age, but the ability to get the needed sleep does decrease with age. Multiple causes could be responsible for reduced capability to achieve sufficient sleep with age, including medical or psychiatric illnesses, life changes (e.g., retirement, bereavement, decreased social interaction), environmental changes (e.g., placement in a nursing home) and polypharmacy. If insomnia is not treated, there is high risk to suffer from several psychosomatic disorders; it may reduce mental capacity of an individual, reduce efficacy and increase the chances of 5 various types of accidents. In contemporary medicine, various sedatives, tranquilizers and hypnotics drugs like zolpidem, temazepam (benzodiazepines, non-benzodiazepines) etc. are being used, but till now, no curative management for Geriatric Insomnia is found; on other hand those drugs are having huge side effects after long-term use rather that relief. So here comes the relevancy of the Ayurvedic principles to treat the insomnia. Many Ayurvedic formulations are effective in treating insomnia but there are less evidences available and less studies have been done on insomnia in Geriatric Population. It is a vulnerable population & due to vata vruddhi, pitta vitiation, dhatu-kapha kshayata they suffer from various metabolic disorders, which may in turn lead to anidra. Hence the administration of such a drug which corrects metabolism, dosh-dhatu vaishamya and induce proper sleep would be helpful and minimal quantity, acceptability, palatability of the drug is also a necessity. So, drug with Vata-Pittahara, Kaphakara, Dhatuposhaka, Mastishka Shamaka, Nidrajanaka, Nadibalya and Rasayana is to be chosen for study. Thus, this study is an effort to evaluate the effect of the drug SARPAGANDHA CHOORNA YOGA in geriatric population.

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
40
Inclusion Criteria
  1. Individuals above & equal to 60 years of age having insomnia of minimum 3 months duration 2) Either sex 3) Insomnia Severity Index above score 7.
Exclusion Criteria
    1. Patients with k/c/o psychiatric illness like Schizophrenia, Major depressive disorder, Psychosis, Epilepsy, Anxiety disorders, etc., 2) Patients with k/c/o Alcohol Dependency or Drug dependency and Hypotension.
    1. Patient with other k/c/o sleep disorders like Narcolepsy, Breathing-related Sleep Disorder, Circadian Rhythm Sleep Disorder, Parasomnia, Hypersomnolence, etc., 4) Patients with other k/c/o illness like Asthma, Malignancies, Liver Cirrhosis, Chronic Renal Failure, etc., 5) Use of Hypnotics by Prescription, Psychotherapy within the past 4 weeks.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Srapagandha Choorna Yoga capsule will be helpful in the improvement of quality and quantity of sleep and quality of life amongst geriatric population and hence better management of Anidra (Insomnia) through0th day 15th day and 30th day
1)Insomnia Severity Index0th day 15th day and 30th day
Secondary Outcome Measures
NameTimeMethod
Srapagandha Choorna Yoga capsule will be helpful in the improvement of quality & quantity of sleep & quality of life amongst geriatric population & hence better management of Anidra (Insomnia) through1) Ayurvedic Assessment Parameters

Trial Locations

Locations (1)

KLEs Ayurveda Hospital and Research Center Shahapur Belagavi

🇮🇳

Belgaum, KARNATAKA, India

KLEs Ayurveda Hospital and Research Center Shahapur Belagavi
🇮🇳Belgaum, KARNATAKA, India
Dr Omkar Devidas Ingale
Principal investigator
9405047189
omkaringale11@gmail.com

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