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Effectiveness of Sagalanoi Chooranam (Polyherbal Powder) in the management of Thookaminmai (Insomnia)

Phase 2
Completed
Conditions
Health Condition 1: F510- Insomnia not due to a substance orknown physiological condition
Registration Number
CTRI/2022/02/040108
Lead Sponsor
ational Institute of Siddha
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
10
Inclusion Criteria

Patients reporting with symptoms of Thookaminmai (Insomnia)

1. difficulty falling asleep, staying asleep, or nonrestorative sleep;

2. this difficulty is present despite adequate opportunity and circumstance to sleep;

3. this impairment in sleep is associated with daytime impairment or distress; and

4. this sleep difficulty for at least 3 times per week and for at least 1 month.

Exclusion Criteria

Patients with a Known cases of

1. Uncontrolled Hypertension.

2. Thyroid dysfunction

3. Diabetes

4. Chronic renal failure

5. Neurological disease

6. Obstructive sleep apnoea syndrome

7. Coronary disease

8. Pregnancy and lactation

9. Malignancy

10. Drug addicts

11. Shift Workers & Drivers

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Primary Outcome will be assessed by comparing scores of Pittsburgh Sleep Quality Index pre and post treatmentTimepoint: 2 Months - Screening <br/ ><br>2 Months - Patient Enrollment <br/ ><br>2 Months - Outcome Assessment
Secondary Outcome Measures
NameTimeMethod
Secondary Outcome will be assessed by comparing scores of Perceived Stress Scale 14 pre and post treatmentTimepoint: 2 Months - Screening <br/ ><br>2 Months - Patient Enrollment <br/ ><br>2 Months - Outcome Assessment
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