Effect of Talamuli (Curculigo orchioides Gaertn.) choorna with Go ksheera (Cow’s milk) in Perimenopausal symptoms.
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- Changes in the level of symptoms are assessed as outcome variables as per the Greene Climacteric Scale.
Study Overview
Brief Summary
The above study deals with the effect of Talamuli choorna with Go ksheera in managing Perimenopausal symptoms which is assessed as per the Greene Climacteric Scale. The study also aims to evaluate the pharmacognostical, phytochemical, HPTLC and Ayurvedic parameters of Talamuli rhizome and Talamuli choorna. Patients in the 40-55 years coming under the inclusion ciriteria will be administered Talamuli choorna orally in the dose of 3 gm with125 ml cow’s milk twice daily(7 am and 7 pm) before food for a duration of 30 days.Assessment will be done pre and post treatment based on the Greene Climacteric Scale.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 40.00 Year(s) to 55.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Females diagnosed to have perimenopausal symptoms as per the Greene Climacteric Scale.
- •Greene Climacteric scale score above
- •Patients willing to give written consent.
Exclusion Criteria
- •Surgical menopause.
- •Any known case of malignancy.
- •Psychiatric disorders.
- •Uncontrolled chronic and systemic illness.
Outcomes
Primary Outcomes
Changes in the level of symptoms are assessed as outcome variables as per the Greene Climacteric Scale.
Time Frame: Changes in the level of symptoms are assessed as outcome variables as per the Greene Climacteric Scale before treatment(0th day), during treatment for 30 days(31st day) and after follow up for 30 days without medication (61st day)
Psychological symptoms
Time Frame: Changes in the level of symptoms are assessed as outcome variables as per the Greene Climacteric Scale before treatment(0th day), during treatment for 30 days(31st day) and after follow up for 30 days without medication (61st day)
Somatic symptoms
Time Frame: Changes in the level of symptoms are assessed as outcome variables as per the Greene Climacteric Scale before treatment(0th day), during treatment for 30 days(31st day) and after follow up for 30 days without medication (61st day)
Vasomotor symptoms
Time Frame: Changes in the level of symptoms are assessed as outcome variables as per the Greene Climacteric Scale before treatment(0th day), during treatment for 30 days(31st day) and after follow up for 30 days without medication (61st day)
Secondary Outcomes
- Pharmacognostical, phytochemical, HPTLC & Ayurvedic parameters(Rasa, Guna, Virya & Vipaka) of Talamuli(Curculigo orchioides Gaertn.)Rhizome & Talamuli choorna.(15 days before commencement of the study.)
Investigators
RINSHA SHAREEF
Government Ayurveda College Tripunithura