Comparative effect of Sahadevi Ghan Vati and Tablet Zolpidem in the treatment of Primary Insomnia

Evaluation of the comparative efficacy of Sahadevi Ghan Vati versus Tablet Zolpidem in the management of Anidra ( Primary Insomnia)- A Randomized Controlled Trial - Nil

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/10/095548

Enrollment

Registered

2025-10-01

Start date

Unknown

Completion date

Unknown

Last updated

2025-10-13

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

Conditions

Health Condition 1: G470- Insomnia

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Informed Consent: Ability and willingness to provide written informed consent. 2. Patients of either sex, between the age group 18 and 65 years 3. Diagnosis: Primary insomnia as per DSM-IV-TR criteria 4. Insomnia Severity Index (ISI) Greater than 7 5. Sleep latency greater than 30 minutes 6. Total sleep time less than 6 hours per night 7. Duration Symptoms present for at least 1 month

Exclusion criteria

Exclusion criteria: Anidra due to alcohol or drug abuse 2. Insomnia with major psychiatric illness like schizophrenia, depressive psychosis, epilepsy, bipolar disorder etc. 3. Patients with drug dependency were excluded. 4. Patients having acute illness like cardiovascular accidents, myocardial infarction and chronic obstructive pulmonary diseases. 5. Pregnant or lactating women. 6. Participation in another clinical trial within the past 3 months 7. Use of sedative-hypnotic medication within 1 week prior to the study. 8. Other sleep disorders (e.g., sleep apnea, narcolepsy, restless leg syndrome).

Design outcomes

Primary

Measure	Time frame
Enhance sedative effect of Sahadevi Ghan Vati in the management of Anidra (Primary Insomnia)Timepoint: In 4 weeks	—

Secondary

Measure	Time frame
improved sleep qualityTimepoint: 30 days	—

Countries

India

Contacts

Public ContactDr Gauri Thakre

Mahatma Gandhi Ayurved College Hospital and Research Centre Salod (H) Wardha

ayurrulz@gmail.com9404337799

Outcome results