Treatment of difficulty in staying asleep with Unani medicine Raughan-e-Kadu Shiree
- Conditions
- Health Condition 1: F510- Insomnia not due to a substance orknown physiological condition
- Registration Number
- CTRI/2023/01/048980
- Lead Sponsor
- Central Council for Research in Unani Medicine CCRUM New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Subjects with males, females and trans-genders between the age group of 18 to 60 years.
2. Subjects with complaining of insomnia that fulfils the diagnostic criteria of Insomnia Disorder of DSM â??V.
1. Patients not fulfilling the diagnostic criteria of Insomnia Disorder of DSM-V.
2. Acute illness, fevers or painful conditions.
3. Known patients of Obstructive sleep apnea syndrome,Central Sleep-Apnea Syndrome, Narcolepsy,Breathing related sleep disorder, Circadian rhythm sleep-wake disorder, parasomnia.
4. Known cases of Restless Leg Syndrome, Periodic Limb Movement Disorder.
5. Alcohol or drug abuse within past six months.
6. Pregnant and Lactating Women.
7. Patients with drug abuse and medication.
8. Known patients of Asthma.
9. Known Patients of Migraine or Headache.
10. Known Drug users of Glucocorticoids.
11. Known cases of Parkinson, Chorea, Epilepsy and Dementia.
12. Known patients of skin diseases like Eczema, Scabies and Psoriasis.
13. Known cases of Chronic Obstructive Pulmonary disease.
14. Known patients of mental diseases.
15. Known patients of Cardiac disease
16. Participation in another study or previous participation in similar study.
17. Subjects who are not willing to take part in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in sign and symptoms of Sahr(Insomnia) including sleepiness during the day, general tiredness, irritability and problem in concentration. Insomnia Severity Index (ISI) and Pittsburgh Sleep Quality Index (PSQI) will be used for the assessment of efficacy.Timepoint: On baseline, 7th and 14th day
- Secondary Outcome Measures
Name Time Method Haematological and biochemical assessment for safety assessmentTimepoint: On baseline and 14th day