A Prospective Double Blinded, Randomised, Placebo-Controlled Study to Evaluate Safety and Efficacy of Two (2) Herbal Formulations in Reducing Menopausal Symptoms in Otherwise Healthy Women.

Category Primary study
Registry of TrialsANZCTR
Year 2015
INTERVENTION: 1. The Active intervention 1 is a 0 size blue‐green hard gelatin capsules containing Tinospora Cardifolia 75mg, Asparagus racemosus 100mg, Withania somnifera 100mg, Commiphora mukul 225mg. (1 capsule, taken twice daily for 3 months) 2. The Active intervention 2 is a 0 size blue‐green hard gelatin capsule containing 300mg of a standardised extract of Trigonella foenum graecum (Fenugreek) seed extract and 30mg of the flow agent maltodextrin. (1 capsule, taken twice daily for 3 months) Compliance is measured by regular follow up (telephone, text and email) and the return of trial bottles (with any unused product) at completion of the trial. CONDITION: Menopause PRIMARY OUTCOME: Symptoms of Menopause assessed using the MENQOL questionnaire. SECONDARY OUTCOME: Safety of Investigational products ‐ serum assays for red blood cells, white blood cells and liver function INCLUSION CRITERIA: Heterosexual females aged between 40 and 65 years Experiencing menopausal symptoms Otherwise healthy Written informed consent provided
Epistemonikos ID: 6f503f935904f9be06da4acb06aad8126d56eccd
First added on: Aug 23, 2024