Management of Insomnia by Ayurvedic Errhine Therapy

Phase 3

Not yet recruiting

• Conditions: Mental disorder, not otherwise specified. Ayurveda Condition: NIDRANASAH/ASVAPNAH, (2) ICD-10 Condition: G||Mental Health. Ayurveda Condition: NIDRANASAH/ASVAPNAH,

• Registration Number: CTRI/2023/01/049059
• Lead Sponsor: Mahatma Gandhi Ayurved College Hospital And Research Centre

Brief Summary

the volunteer will be inform about the study protocol willing participants will be randomly selected as per computer generated table. clinical research format will be prepared and validated prior to the study approval will be taken from IEC,MGACHRC, Salod (hirapur), wardha and CTRI registration will be done. After selection, each participants will be tested individually and selected according to selection criteria. they are divided into two groups the trial is parallel group, randomized, single blind clinical, standard controlled trial. it will include 15 days treatment period and 16th and 30th day follow up period.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-31
• Last Update Posted: 2023-02-01

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1.Patients who are willing to give written inform consent 2.Patients either gender age between 20 to 60 years 3.Patients who are fit for Nasyakarma 4.Patient with controlled hypertension 5.ICD10 criteria for primary insomnia F51 point 01.

Exclusion Criteria

1.Patients less than 20 years and more than 60 years 2.Pregnant women and lactating mothers 3.Patient with co morbidities Example uncontrolled Hypertension DM2 Thyroids and Cardiac disorders 4.Patient not fit for Nasya karma Pratishyaya Trushna Ajirna Rajaswala etc 5.Patient with drug dependency like Anti histamines Narcotics 6.Occupational disorder.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the efficacy of Shankhapushpi Taila and Ksheerabala Taila in Pitssburg Sleep Quality Index Insomnia severity index and Quality of life	15 days

Secondary Outcome Measures

Name	Time	Method
To assess the efficacy of Shankhapushpi Taila and Ksheerabala Taila in Pitssburg Sleep Quality Index Insomnia severity index and Quality of life	0 day 15th day 30th day

Trial Locations

Locations (1)

Mahatma Gandhi Ayurved College Hospital and Research Centre; 🇮🇳 Wardha, MAHARASHTRA, India

Mahatma Gandhi Ayurved College Hospital and Research Centre

🇮🇳Wardha, MAHARASHTRA, India

Dr Annya Gautam

Principal investigator

8218406491

ananyagautam68@gmail.com