None listed
Conditions
Interventions
None listed
Sponsors
Sidhva Herbal and Foods Pondicherry
Eligibility
Inclusion criteria
Inclusion criteria: 1) Male/females of greater than or equal to 18 years of age at the time of consent 2) Patient / Legally Acceptable Representative who can and willing to provide Informed Consent 3) Confirmed anemia 4) Clinically stable for at least 1 month prior to entry into the study 5) Score on the Insomnia Severity Index (ISI) measure greater than or equal to 15
Exclusion criteria
Exclusion criteria: 1) Pregnant or lactating women or women of childbearing potential who did not use oral contraceptives or an intrauterine device 2) Administration of another investigational drug within 1 month before screening or planned during the study period 3) Patients who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol 4) Diagnosis of other primary sleep disorders 5) Psychotherapy within the past six months 6) Shift workers 7) Current or expected use of hypnotic medications 8) Renal or hepatic disease 9) History of Neurological disorder or cardiovascular disease raising safety concerns 10) Excessive coffee or cigarette use 11) Recent surgery 12) Current alcohol/substance use disorder 13) Current major depressive episode
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Improvement in the Immune Status Questionnaire (ISQ) from baseline to end of the study 2.Improvement in Hemoglobin level from baseline to end of the studyTimepoint: 2 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Improvement in the Liver function test (LFT) Parameters. 2.Improvement in the (Pittsburgh Sleep Quality Index PSQI) from base line to end of the study. 3.Number of Treatment Emergent Adverse Event (TEAE) and Treatment Emergent Serious Adverse Event (TESAE)Timepoint: 2 months | — |
Countries
India
Contacts
Public ContactDr MS Ramasamy
Sanjeev Biomedical Research Center
Outcome results
None listed