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A Study to Find Out How Vibhitaki Capsules and Vacha Dhupana Therapy Help Improve Sleep in Working Women with Sleeplessness

An Open Label Comparative Clinical Study To Evaluate The Effect Of Vibhitaki Phala MajjaTerminalia Belerica Capsule and Aromatherapy With Vacha Acrus Calamus Linn Dhupa in Working Women VisAVis Primary Insomnia - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/092523
Enrollment
30
Registered
2025-08-06
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

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

None listed

Sponsors

nil
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Working women fulfilling diagnostic criteria of Insomnia as per DSM-5 and ICD-10. 2) Patients are selected of age group between 20-40years. 3) Patients willing to sign informed consent.

Exclusion criteria

Exclusion criteria: 1) Patients suffering from any systemic illness, psychiatric illness or disorder and other metabolic disorders interfering with the treatment protocol. 2) Pregnant and lactating women. 3) Patient suffering from Substance abuse, Circadian rhythm disorder, Parasomnia.

Design outcomes

Primary

MeasureTime frame
Assessment criteria: Parameters will be scored by standard method and will be assessed before and after treatment on 0 th , 14 th and 28 th day and will be analysed statistically. 1) Athens insomnia scale 2) Insomnia severity index 3) Baseline values of Visual analogue scale (0-10) of Angamarda, Shirogourava, Jrumba, Jaadya, Glani, Bhrama, Apakthi, Tandra compared with values of Visual analogue scale (0- 10) on 28 th day. 4) WHO Quality of life scale-Brief Scored parameters will be analysed statistically after the treatment. All the subjective parameters and scales will be assessed using Wilcoxon signed rank test within the groups and Mann-Whitney U test in between the groups.Timepoint: observation will be made on 0th,14th and 28th day

Secondary

MeasureTime frame
quality of lifeTimepoint: 0th day and 28th day

Countries

India

Contacts

Public ContactDr Sughosh S Mujumdar

Shri Dharmashtala Manjunatheswara College of Ayurveda, Hospital and Research centre, Kuthpady, Udupi

ayurvijay25@gmail.com9448139919

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026