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

Clinical validation of Unani pharmacopoeial formulation Raughan-e-Kaddu-Shireen in Sahr (Insomnia)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/01/048980

Enrollment

165

Registered

2023-01-13

Start date

Unknown

Completion date

Unknown

Last updated

2023-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F510- Insomnia not due to a substance orknown physiological condition

Interventions

Intervention1: Raughan-e-Kadu Shireen: 1ml of oil to be used topically on scalp and sole with fingers for minimum 10 minutes once at night daily for two weeks Control Intervention1: NIL: NIL

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Secondary

Measure	Time frame
Haematological and biochemical assessment for safety assessmentTimepoint: On baseline and 14th day	—

Primary

Measure	Time frame
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	—

Countries

India

Contacts

Public ContactDr Pradeep Kumar

Central Council for Research in Unani Medicine (CCRUM)

ccrum507@rediffmail.com9213511298

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026