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A Study to Evaluate the Effect of Herbal Decoction, Head Application Therapy, and Their Combination in Patients with Insomnia

A Comparative Study on the Efficacy of Kakajangha (Dicliptera paniculata (Forssk.) I. Darbysh.) Mool Kwath, Shirolepa and Their Combined Use in the Management of Anidra (Insomnia) - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/02/103431
Enrollment
72
Registered
2026-02-09
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: F05- Delirium due to known physiological condition

Interventions

None listed

Sponsors

Ayurvedic And Unani Tibbia College And Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Both sexes patients of age group between 20 to 60 years. 2. Anidra along with patients complains of Angamarda, Shirogaurava, Jrumbha, Jadyata, Glani, Bhrama and Apakti - either some of these or all 3. Patients who are willing to participate and give written informed consent. 4. Patients suffering from following type of disturbed sleep pattern. (a) Difficulty taking sleep at the beginning of the night (b) Difficulty in maintain the sleep (c) Difficulty to returning to sleep after awakening in the middle of the night or wakening early in the morning (d) Patients having anidra more than 1 month

Exclusion criteria

Exclusion criteria: Secondary insomnia and patients suffering from fatal familial insomnia. 2. Patients on hypnotic medicine or other drugs known to cause drowsiness. 3. Patients suffering from congenital anomalies 4. Patients with a history of cardiovascular disease or uncontrolled hypertension, uncontrolled diabetes. 5. Subjects with comorbidities such as Tuberculosis, immunocompromised states such as HIV, history or active malignancy etc. 6. Hereditary Disease 7. Taking treatment for major psychiatric disorders. 8. Subjects on systemic or oral steroids for equal and greater than 3 weeks in the last 3 months are often excluded, because it may affect the immune system, sleep, or study outcomes. 9. Patients with alcohol or drug dependency. 10. Patients who have participated in any clinical trial in the past 6 months.

Design outcomes

Primary

MeasureTime frame
Ayurvedic Assessment of Nidra Insomnia Severity Index (ISI) Score (validated scale for insomnia). Change in serum cortisol level from baseline Timepoint: 3 months

Secondary

MeasureTime frame
Pittsburgh Sleep Quality Index (PSQI) assessment of global sleep quality. Incidence of adverse events, if any. Change in the laboratory safety parameters (LFT, KFT) from baseline. To confirm that the collected kakajangha sample meets official API standards, ensuring its quality and medicinal authenticity Timepoint: 3 months

Countries

India

Contacts

Public ContactDr Vikas Singh

Ayurvedic And Unani Tibbia College And Hospital Karol Bagh New Delhi

dr.monika0@gmail.com9456480861

Outcome results

None listed

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