A clinical trial to study the efficacy of Nasya karma with Jyothishmati Taila and Oral administration of Ashwagandha Root Extract in the managementof Sleep Onset Insomnia(Nidra Nasha)

Not yet recruiting

• Conditions: Other specified degenerative disorders of nervous system in diseases classified elsewhere. Ayurveda Condition: NIDRANASAH/ASVAPNAH,

• Registration Number: CTRI/2022/07/044456
• Lead Sponsor: Dr V Bharathi

Brief Summary

A clinical trial will be done to evaluate the efficacy of Jyotishmati taila nasya and ashwagandha root extract orally in the management of Insomnia vis-a-vis Nidra Nasha and to validate scientifically the observations that would significantly change the signs and symptoms of Insomnia. Nasya is a unique procedure for urdhwa jatrugata rogas which is mentioned in several ayurvedic texts like Charaka Samhita and Susruta Samhita and will be performed on 50 patients with Jyotishmati Tailam which has a reference from Bhavaprakasa along with Ashwagandha root extract 500 mg oral administration for 40 days. The study would be conducted in India aimed to complete in 3 years and the trial time being 21 months. Primary out-come measures will be relief in signs and symptoms(Subjective Parameters)

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-08
• Last Update Posted: 2022-07-27

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Patients of age group 20-60 years, irrespective of gender, with symptoms like disturbed sleep, fatigue, heaviness of head, heaviness of body and frequent yawning, with no hormonal imbalances.

Exclusion Criteria

Patients age less than 20 years, more than 60 years, with chronic illnesses, drug addicts, alcoholics, psychiatric patients, pregnant and lactating mothers.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relief in Signs and Symptoms and significant improvement of subjective parameters, teststo 50% baseline	Treatment period of 40 days with follow up at 15-40-60-90 days with active follow up of 3 months

Secondary Outcome Measures

Name	Time	Method
Relief in Signs and Symptoms and significant improvement of Objective parameters	Treatment period of 40 days with follow up at 15-40-60-90 days with active follow up of 3 months

Trial Locations

Locations (1)

DR N.R.S. GOVT. AYURVEDIC COLLEGE; 🇮🇳 Krishna, ANDHRA PRADESH, India

DR N.R.S. GOVT. AYURVEDIC COLLEGE

🇮🇳Krishna, ANDHRA PRADESH, India

Dr V BHARATHI

Principal investigator

09440486521

bharathivtkr430@gmail.com