A Study on the Effectiveness of a Unani Herbal Formulation with Roughan-e-Kishneez in the Management of Insomnia

Evaluation Of Efficacy And Safety Of Compound Unani Formulation Along With Roughan-E-Kishneez In The Management Of Sahr (Insomnia Disorder): A Single-Arm Clinical Trial - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/01/102036

Enrollment

Registered

2026-01-27

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-02

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: Topical- Roughan-e-Kishneez Oral- Herbal formulation: Topical- Roughan-e-Kishneez head massage one time at night, Oral- Badranjboya(Melissa officinalis L.)-7gms, Khuzama(Lavandula angu

Eligibility

Inclusion criteria

Inclusion criteria: Patients diagnosed with insomnia disorder as per ICSD-3 TR criteria. Patients with score of (8-21) in insomnia severity index (I.e., mild to moderate) Pittsburgh sleep quality index (PSQI) global score more than 5 up to 15. Ability and willingness to provide written informed consent and willingness to adhere to the treatment protocol.

Exclusion criteria

Exclusion criteria: Patients with other sleep disorders (narcolepsy, parasomnias, circadian rhythm sleep disorder. Sleep related breathing disorder (OSA, RLS). Patients with history of substance abuse/use. Patients with diagnosed other psychiatric and neurological disorders (epilepsy, Parkinson s, major depressive disorder, bipolar disorder). Patients with current use of hypnotic medications in the last 2 weeks. Patients with chronic pain conditions and medical illnesses that significantly impair sleep. (arthritis, CVA, renal failure, liver diseases, COPD, uncontrolled HTN etc.). Pregnant and lactating women. Patients with H/O participation in other study within last 2-3 months.

Design outcomes

Primary

Measure	Time frame
A reduction in 6 points in ISI will be considered significant.Timepoint: 10th, 20th, 30th day	—

Secondary

Measure	Time frame
A reduction in 3 points will be considered clinically meaningful.Timepoint: 10th, 20th, 30th day	—

Countries

India

Contacts

Public ContactDr Ayesha Siddiqua

Government Nizamia Tibbi College

dr.faroqui@gmail.com9849139356

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026