Efficacy of Ayurvedic Protocol as an add-on therapy to standard of care in insomnia during chemotherapy cycles: A non - randomized active control - group study

Efficacy of Shirothalam (Kachuradi Churnam and Ksheerabala 101) and Padabhyangam (Ksheerabala Thailam) as an add-on therapy to standard of care in insomnia among patients undergoing chemotherapy: A non-randomized active control-group study.

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/07/044186

Enrollment

Registered

2022-07-20

Start date

Unknown

Completion date

Unknown

Last updated

2023-02-06

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: 1) Aged 18 years â?? 60 years with no discrimination of sex, religion, gender and economic status 2) Cancer patients undergoing chemotherapy, diagnosed with insomnia as per DSM V with an ISI score of 15-21 (Clinical Insomnia with moderate severity) and 22-28 (clinical insomnia severe). 3) Life expectancy >3 months. 4) Those who are willing to participate in this study and sign informed consent forms.

Exclusion criteria

Exclusion criteria: 1. Cancer patients undergoing chemo-radiation 2. Cancer patients planned for minor or major surgery 3. Cancer patients with abnormal cognition and speech causing difficulty in comprehension, and expression.

Design outcomes

Primary

Measure	Time frame
Primary outcome â?? Parameters from ISI scale Timepoint: 0th day and 15th day	—

Secondary

Measure	Time frame
Secondary outcomes â?? Parameters from PSQI scaleTimepoint: 0th day and 15th day	—

Countries

India

Contacts

Public ContactDr Arathi P

Amrita School of Ayurveda

dr.arathi.prabhas@gmail.com7560862683

Outcome results