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Study to evaluate effect Of oral administration of Jatamansi tablet with Counselling Therapy for Improving Sleeplessness and quality of sleep

Double blind placebo control randomised clinical trial to evaluate add on effect Of oral administration of Jatamansi tablet with cognitive behavioral therapy For insomnia (CBT-I) in the management of insomnia during perimenopause - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/02/103166
Enrollment
64
Registered
2026-02-06
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Health Condition 1: F40-F48- Anxiety, dissociative, stress-related, somatoform and other nonpsychotic mental disorders

Interventions

None listed

Sponsors

Dr Savita Pawar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Women aged 45 to 55 years. Insomnia Severity Index. (ISI) (score in between 8-21 indicating sub threshold insomnia to moderate insomnia) Duration of insomnia greater than 1 month, greater than 3 nights/week. Able to understand and comply with CBT instructions. Give written informed consent. Mild to moderate case of insomnia.

Exclusion criteria

Exclusion criteria: Known cases of Hypertension, Thyroid disorders, and Diabetes Mellitus. PHQ-9 Depression scale Score greater than 5 Under medication for any psychological or psychiatric disorders, substance use. Habitual caffeine intake exceeding 400mg/day(equivalent to approximately 4 cups (240 ml each) of brewed coffee or any comparable caffeine sources Current insomnia treatment. Known case of pelvic pathology. Hormonal therapy. Severe case of insomnia. No access to mobile phones and internet.

Design outcomes

Primary

MeasureTime frame
Insomnia severity reduction: A clinically significant improvement defined as a greater than or equal to 7-point reduction in ISI score from baseline to 4 weeks. Sleep quality improvement: A greater than or equal to 3-point reduction in PSQI score from baseline to 4 weeks considered clinically meaningful. Timepoint: 4months

Secondary

MeasureTime frame
Insomnia severity reduction: A clinically significant improvement defined as a greater than or equal to 7-point reduction in ISI score from baseline to two weeks. Quality of life enhancement: A greater than or equal to 10% increase in Q-LES-Q-SF score from baseline to 4 weeks indicating improved satisfaction and enjoyment. Timepoint: 4 months

Countries

India

Contacts

Public ContactDr Parvathy Unni Krishnan

Amrita school of ayurveda kerala india

parvathyunnikrishnannair@gmail.com9497882775

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026