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A study to see the effect of pippalimula churna as compared to jatamansi churna in the treatment of lack of sleep (Nidranash)

Phase 2
Conditions
Health Condition 1: G998- Other specified disorders of nervous system in diseases classified elsewhere
Registration Number
CTRI/2020/11/029288
Lead Sponsor
Dr Roshani Shekhar Patil
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1. Participant diagnosis with primary insomnia.

2. INSOMNIA SEVERITY INDEX more than 7 and <21.

3. A female participant should have negative

pregnancy test and agree to use contraceptive

throughout study.

4. patient willing to follow diet and behavioral

regimen

Exclusion Criteria

1.History of diagnosis of another sleep diorder

2.Difficulty sleeping due to medical conditions

history of neurological disorder,bipolar disorder,psychotic disorder,post traumatic stress disorder,current psychiatric diorder that require medication.

O3.On going depression and genralized anxiety disorder

4.History of current evidence of clinically significant cardiovascular disoerder or ecg at pre study visit.

5.Taking some prohibited medication

6.Subject with habbit of smoking cigarette etc

7.Subject with history of hep B and C,DM, night shift duty

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To get cured of Nidranash (primary insomnia)Timepoint: A cure shall be assessed in 2 follow ups in 14 days
Secondary Outcome Measures
NameTimeMethod
To get cured from lack of sleep or distrubed sleep to have healthy and stress free lifeTimepoint: 14 days
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