Efficacy of Vachadi gana ghan vati versus Lasunadi vati in the management of Artvakshaya (Oligomenorrhoea) in overweight women- an open label randomized comparative clinical trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Reduction in inter menstrual interval and Reduction in body weight
Study Overview
Brief Summary
This study investigates the efficacy of two Ayurvedic formulations, Vachadi Gana ghan vati and Lasunadi vati*,* in managing Oligomenorrhea (infrequent menstrual bleeding) in overweight women. Oligomenorrhea is commonly associated with overweight individuals and is considered a manifestation of vata kapha imbalance according to Ayurveda.
The study design involves a prospective open-label randomized comparative clinical trial with 72 overweight women, divided into two groups receiving either Vachadi Gana ghan vatior Lasunadi vati*.* Primary objectives include assessing the efficacy in managing Oligomenorrhea, while secondary objectives focus on evaluating metabolic parameters, changes in weight, and bleeding amount. Various data sources including literature, drug preparation details, and clinical assessments are utilized.
Assessment methods include subjective parameters such as interval and amount of bleeding, pain during menstruation, and acanthosis nigricans, alongside objective measures like changes in body weight, waist-hip ratio, and laboratory parameters. Statistical analysis will be conducted using appropriate tests to determine significant outcomes.
The discussion emphasizes Ayurvedic principles in understanding and treating Oligomenorrhea, particularly focusing on vata kapha imbalance and the concept of avarana(obstruction) in the artava vaha srotas*.* Vachadi Gana ghan vati is highlighted for its potential in promoting agni*,* pacifying kapha, and alleviating avarana*.* The study underscores the importance of lifestyle modifications alongside pharmacological interventions, reflecting the holistic approach of Ayurveda.
By integrating Ayurvedic principles with modern research methodologies, this study aims to provide valuable insights into the efficacy of these traditional formulations in managing Oligomenorrhea in overweight women, thus contributing to bridging the gap between traditional wisdom and contemporary healthcare practices.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 40.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Female patients of age group between 18 to 40 years Married and Unmarried females Interval of menstrual cycles 38 to 90 days in the past 2 cycles or less than 8 menstrual periods in one year Oligomenorrhoea associated with pelvic pain Oligomenorrhoea associated with Hypomenorrhea BMI 25 to 29.9 associated with normal or increased Waist Hip ratio Diagnosed patients of PCOD with cycle interval of less than 90 days.
Exclusion Criteria
- •Female patients below 18 years and above 40 years Hyperthyroidism and uncontrolled Hypothyroidism Patient taking any other kind of medication from three months before treatment or taking presently BMI less than 25 and more than 29.9 Hyperprolactinemia History of Heavy menstrual bleeding more than 80ml per day or more than 7 days in the last 2 cycles which is assessed by PBAC score Patients having any history of diabetes mellitus hypertension Patients with any kind of congenital disease Patients having any pelvic pathologies like uterine fibroid adenomyosis endometriosis PIDs etc.
Outcomes
Primary Outcomes
Reduction in inter menstrual interval and Reduction in body weight
Time Frame: at baseline and after 90 days
Secondary Outcomes
- Reduction in values of triglycerides cholesterol LDL testosterone levels and Changes in waist-hip ratio and changes in other associated symptoms like amount of bleeding and pelvic pain and Conception in case of Infertility(at baseline and after 90 days)
Investigators
Dr Monika Kaushik
Shri Dhanwantary Ayurvedic College and Hospital