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
Phase 4
- Conditions
- Health Condition 1: G470- Insomnia
- Registration Number
- CTRI/2022/07/044186
- Lead Sponsor
- Dr Arathi P
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method