Health Condition 1: F510- Insomnia not due to a substance orknown physiological condition
Conditions
Interventions
Intervention1: Polyherbal Unani Formulation: 9gm at night for 28 days
Intervention2: Polyherbal Unani Formulation (Powder): 9gm at night for 28 days
Control Intervention1: NIL: NIL
Sponsors
Ayurvedic and Unani Tibbia College and Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1.Diagnosed with primary insomnia as per ICSD-3 criteria. 2.Willing to give written informed consent and comply with study procedures. 3.Willing to discontinue other medications or therapies for insomnia during the trial.
Exclusion criteria
Exclusion criteria: 1.History of major medical illness: uncontrolled hypertension, diabetes mellitus, hepatic or renal dysfunction, respiratory (COPD), cardiovascular or neurological diseases. 2.Use of sedatives, antidepressants, hypnotics, or other CNS-affecting medications within the last 2 weeks. 3.Pregnant or lactating women. 4.Known allergy or hypersensitivity to any component of the Unani formulation. 5.Presence of other sleep disorders, such as: Obstructive Sleep Apnea (OSA), Restless Legs Syndrome, Narcolepsy, Circadian rhythm disorder. 6.Current or recent history (past 6 months) of alcoholism or drug dependence
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the safety and efficacy of the proposed Unani Polyherbal Formulation in the management of Insomnia on scientific parameters.Timepoint: 1.To evaluate efficacy: Assessment of Insomnia Severity Index on baseline and 28th day. 2.To evaluate safety: Haemogram , LFT, KFT at baseline and 28th day. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the effects of Unani Polyherbal Formulation on the Quality of life of the patient of Insomnia.Timepoint: Assessment of Quality of life Index at baseline and after 28th day. | — |
Countries
India
Contacts
Public ContactMisbah Shafaq
Ayurvedic and Unani Tibbia College and Hospital
Outcome results
None listed