Health Condition 1: null- Antipsychotic drug-induced hyperprolactinemia
Conditions
Interventions
Intervention1: Jasmine flower extract nasal drops: Jasmine flower (Jasminum Sambac species) extract: extracted from five hundred grams of jasmine flower added to 375 ml of 90% ethanol and 300 ml de-io
Sponsors
Christian Medical College
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult pre-menopausal women; 2. Aged 18 to 45 years; 3. With oligomenorrhea / amenorrhea and / or galactorrhea for at least 3 months duration; 4. Baseline serum prolactin level more than 25 ng/ml; 5. On a stable dose of antipsychotics for the last 3 months; 6. Residing in or around Vellore (within a 70 kilometer radius; 7. Have access to a refrigerator in or near their homes to store study agents.
Exclusion criteria
Exclusion criteria: 1. Not fulfilling inclusion criteria 2. Definite history of sinusitis or asthma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Biochemical response: Drop in serum prolactin levels by 25 ng/ml over baseline levelsTimepoint: Baseline Day 7 Day 14 Day 21 | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse eventsTimepoint: During study period (day 1 to day 21);Change in prolactin levels over baseline in biochemical respondersTimepoint: Baseline Day 7 Day 14 Day 21;Clinical response: Reversal of amenorrhea or galactorrheaTimepoint: During study period;Compliance to antipsychoticsTimepoint: Day 7 Day 21;Compliance with study agentsTimepoint: Day 7 Day 21;Mean prolactin levelsTimepoint: Baseline Day 7 Day 14 Day 21;Prolactin changes according to mean dose of antipsychotic drugs (in chlorpromazine equivalents)Timepoint: Baseline Day 7 Day 14 Day 21 | — |
Countries
India
Contacts
Public ContactPhilip Finny
Christian Medical College, Vellore
Outcome results
None listed