A RANDOMIZED CONTROLLED CLINICAL TRIAL TO STUDY THE EFFECT OF ASHWAGANDHA LEHA AND NIRGUNDI TAILA PADABHYANGA IN NIDRANASH WITH SPECIAL REFERENCE TO PRIMARY INSOMNIA
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 70
- Locations
- 1
Study Overview
Brief Summary
“A RANDOMIZED CONTROLLED CLINICAL TRIAL TO STUDY THE EFFECT OF ASHWAGANDHA LEHA AND NIRGUNDI TAILA PADABHYANGA IN NIDRANASH WITH SPECIAL REFERENCE TO PRIMARY INSOMNIA”
**INTRODUCTION:**Ayurveda emphasizes Nidra (sleep) as one of the three pillars of life (Trayopasthambha), essential for maintaining physical and mental health. Proper sleep brings balance, strength, nourishment, knowledge, and longevity, while disturbed sleep leads to Nidranash (insomnia), a Vata-dominant disorder affecting both mind and daily functioning. Classical texts describe its causes, symptoms, and treatments such as oil massage, foot massage, nourishing diet, and calming therapies to restore balance
Insomnia affects 10–30% of the global population and about 33% of adults in India, significantly impairing cognitive function, mood, work performance, and overall health. Conventional medicines often cause side effects, whereas Ayurveda offers a natural approach by restoring mind–body balance. Ashwagandha Leha promotes sleep by enhancing GABA activity in the brain, while Nirgundi Taila Padabhyanga helps pacify aggravated Vata, supporting natural and healthy sleep.
SAMPLE SIZE: The sample size for the study will be 60 participants. Considering a 5% dropout rate for each group, the total sample size will be 70 participants.
**Null Hypothesis:**Ashwagandha Leha and Nirgundi Taila Padabhyanga Is Not Effective in sign and symptoms of Nidranash w.s.r. to Primary Insomnia
Alternative Hypothesis : Ashwagandha Leha and Nirgundi Taila Padabhyanga is effective in sign and symptoms of Nidranash w.s.r. to Primary Insomnia.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients with score in range between 8 -21 on ISI Scale.
- •Individuals of either sex, between the age group of 18 to 60 years, regardless of their socio-economic background.
- •Patients presenting with complaints of insomnia, including difficulty in falling asleep, frequent awakenings, early morning awakening, or difficulty maintaining sleep, occurring more than three times a week for at least one month, despite having adequate opportunity for sleep.
- •Presence of associated daytime impairments such as drowsiness, heaviness of the body, fatigue, irritability, reduced memory, and poor concentration.
- •Patients complaining of Ayurvedic clinical features such as Angamarda (body ache), Shirogaurav (heaviness in head), Jrimbha (yawning), Jadyata (sluggishness), Glani(fatigue), Bhrama (dizziness), and Apakti (indigestion) and Tandra (drowsiness).
- •Patients who are willing to participate in the clinical trial.
Exclusion Criteria
- •Patients diagnosed with any other psychiatric disorder who are on medications that may cause sedation or affect sleep patterns.
- •Patients having Insomnia due to severe illness such as cardiac diseases, hypertension, diabetes and other chronic disorders like bronchial asthma, malignancies, liver diseases, chronic renal diseases were excluded from the study.
- •Individuals in physiological conditions such as pregnancy, lactation, or the postpartum (puerperal) stage.
- •Patients suffering from other medical conditions such as hypertension, diabetes, or vertigo.
Investigators
Dr Yogeshwar Sakharam Bhapkar
SMBT AYURVED COLLEGE AND HOSPITAL DHAMANGAON IGATPURI NASHIK