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Effect of Ashwagandha Leha taken internally and Nirgundi oil foot massage help in improving sleep problems, especially in people suffering from primary insomnia.

A RANDOMIZED CONTROLLED CLINICAL TRIAL TO STUDY THE EFFECT OF ASHWAGANDHA LEHA AND NIRGUNDI TAILA PADABHYANGA IN NIDRANASH WITH SPECIAL REFERENCE TO PRIMARY INSOMNIA - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/01/101847
Enrollment
70
Registered
2026-01-22
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: PCS-

Interventions

None listed

Sponsors

Dr Yogeshwar Sakharam Bhapkar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with score in range between 8 -21 on ISI Scale. 2. Individuals of either sex, between the age group of 18 to 60 years, regardless of their socio-economic background. 3. 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. 4. Presence of associated daytime impairments such as drowsiness, heaviness of the body, fatigue, irritability, reduced memory, and poor concentration. 5. 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). 6. Patients who are willing to participate in the clinical trial.

Exclusion criteria

Exclusion criteria: 1. Patients diagnosed with any other psychiatric disorder who are on medications that may cause sedation or affect sleep patterns. 2. 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. 3. Individuals in physiological conditions such as pregnancy, lactation, or the postpartum (puerperal) stage. 4. Patients suffering from other medical conditions such as hypertension, diabetes, or vertigo.

Design outcomes

Primary

MeasureTime frame
To Asses Ashwagandha Leha and Nirgundi Taila Padabhyanga in Nidranash with special reference to Primary Insomnia on the assessment criteria of Nidranash after 15 days of treatment.Timepoint: 0 day 7th Day 15th Day

Secondary

MeasureTime frame
NIlTimepoint: NIL

Countries

India

Contacts

Public ContactDr Yogeshwar Sakharam Bhapkar

SMBT AYURVED COLLEGE AND HOSPITAL DHAMANGAON IGATPURI NASHIK

hiramanwarungase@yahoo.com9420364157

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026