None listed
Conditions
Interventions
None listed
Sponsors
Government of Himachal Pradesh
Eligibility
Inclusion criteria
Inclusion criteria: Female aged between forty and fifty-five years experiencing perimenopausal symptoms. Classified as perimenopausal according to the STRAW plus ten criteria. Early perimenopause defined as menstrual cycle variability of seven days or more. Late perimenopause defined as amenorrhea for sixty days or more but less than twelve months. Menopause Rating Scale score of ten or more. Vaginal Health Index Score of ten or more. Willing and able to participate for a duration of twelve weeks.
Exclusion criteria
Exclusion criteria: Patients with evidence of malignancy. Patients who have undergone surgical menopause. Established cases of any mental illness. Prolonged use of drugs affecting study outcomes for more than six weeks, including corticosteroids, antidepressants, anticholinergics, and hormone replacement therapy. Patients with major systemic diseases requiring long term treatment. Patients who are alcohol dependent and or drug dependent. History of hypersensitivity to any of the trial drugs or their ingredients. Any other condition which the Principal Investigator considers may jeopardize the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relief in associated symptoms related to Perimenopause. Timepoint: shatavari kalpa and shatapushpa orally for 84 days daily and shatavari vaginal gel and shatapushpa vaginal gel intravaginally 3 times a week for 84 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| Level of Oxidative stress markers.Timepoint: before and after trial oxidative stress level. | — |
Countries
India
Contacts
Public ContactDr Tanuja Kanwar
Rajiv Gandhi Government Post Graduate Ayurvedic College & Hospital Paprola Kangra H.P.
Outcome results
None listed