Homoeopathic medicines for the treatment of Insomnia.
- Conditions
- Health Condition 1: G470- Insomnia
- Registration Number
- CTRI/2023/09/057225
- Lead Sponsor
- axmiben Homoeopathy Institute and Research Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Subjects who have been diagnosed as per the DSM-V Diagnostic Criteria for Insomnia.
2.Subjects will be selected irrespective of their sex, socio-economic status, and occupation.
3.Age between 18 to 50 years.
4.If the subject is illiterate then the relatives or family members will be assessed to fill the sleep diary.
5.Subjects who are willing to participate and sign the written informed consent form.
1.Subjects suffering from the complications of insomnia.
2.Subjects are undergoing treatment with non-steroidal anti-inflammatory drugs (NSAIDs), antiemetics, triptans, ergot alkaloids, and estrogen for 2 weeks prior to enrollment in the study.
3.Subjects suffering from uncontrolled systemic illness or psychiatric diseases and/or life-threatening infections.
4.Substance abuse and/or dependence.
5.Pregnant or lactating women.
6.Subjects already undergoing homoeopathic treatment elsewhere for any chronic disease within the last 02 months.
7.Non-compliance to the study treatment/ protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Consensus Sleep Diary CoreTimepoint: At baseline, every month, up to 6 months
- Secondary Outcome Measures
Name Time Method Insomnia Severity Index (ISI)Timepoint: At basline, 03 Months, 06 Months;WHOQOL-BREFTimepoint: At basline, 03 Months, 06 Months