Treatment of difficulty in staying asleep with Unani medicine Raughan-e-Kadu Shireen

Phase 3

Not yet recruiting

Conditions: Insomnia not due to a substance orknown physiological condition,

Lead Sponsor: Central Council for Research in Unani Medicine CCRUM New Delhi

Brief Summary: This study is designed as a single centric open trial in patients with **Sahar (Insomnia)**.After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically at every week. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be two weeks. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.

**Composition of *Raughan-e-Kadu Shireen***

| | | | |

| --- | --- | --- | --- |

|**S.No.**

**Name of the Drug**

**Scientific Name**

**Quantity**

|1.

*Aab Kadu e DaraazTaaza*

*Lazinariasiceraria*

4 ltrs

|2.

*Raughan Kunjad*

*Melissa parviflora*

1kg

Recruitment & Eligibility

Inclusion Criteria

Subjects with males, females and trans-genders between the age group of 18 to 60 years.
Subjects with complaining of insomnia that fulfils the diagnostic criteria of Insomnia Disorder of DSM â€“V.

Exclusion Criteria

Patients not fulfilling the diagnostic criteria of Insomnia Disorder of DSM-V.
Acute illness, fevers or painful conditions.
Known patients of Obstructive sleep apnea syndrome,Central Sleep-Apnea Syndrome, Narcolepsy,Breathing related sleep disorder, Circadian rhythm sleep-wake disorder, parasomnia.
Known cases of Restless Leg Syndrome, Periodic Limb Movement Disorder.
Alcohol or drug abuse within past six months.
Pregnant and Lactating Women.
Patients with drug abuse and medication.
Known patients of Asthma.
Known Patients of Migraine or Headache.
Known Drug users of Glucocorticoids.
Known cases of Parkinson, Chorea, Epilepsy and Dementia.
Known patients of skin diseases like Eczema, Scabies and Psoriasis.
Known cases of Chronic Obstructive Pulmonary disease.
Known patients of mental diseases.
Known patients of Cardiac disease 16.
Participation in another study or previous participation in similar study.
Subjects who are not willing to take part in the study.

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.	On baseline, 7th and 14th day

Secondary Outcome Measures

Name	Time	Method
Haematological and biochemical assessment for safety assessment	On baseline and 14th day

Locations (1): Regional Research Institute of Unani Medicine, Patna
🇮🇳
Patna, BIHAR, India
Regional Research Institute of Unani Medicine, Patna
🇮🇳Patna, BIHAR, India
Dr Md Manzar Alam
Principal investigator
9920245133
manzar.medicine@gmail.com