CTRI/2024/05/066768 [Registered on: 03/05/2024] Trial Registered Prospectively
Last Modified On:
24/04/2024
Post Graduate Thesis
Yes
Type of Trial
Interventional
Type of Study
Drug Biological Ayurveda Diagnostic Preventive Screening
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
Ayurvedic intervention to regulate prolonged interval between two menstrual cycles
Scientific Title of Study
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 Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Monika Kaushik
Designation
PG scholar
Affiliation
Shri Dhanwantary Ayurvedic College and Hospital
Address
Room no 205 A department of prasuti evam stree roga Shri Dhanwantary Ayurvedic College and Hospital sector 46 b chandigarh
Chandigarh CHANDIGARH 160047 India
Phone
9599563553
Fax
Email
kmonika1595@gmail.com
Details of Contact Person Scientific Query
Name
Dr Archana S
Designation
Associate professor in department of prasuti tantra and stree roga
Affiliation
Shri Dhanwantary Ayurvedic College and Hospital
Address
Room no 205 A Department of Prasuti evam Stree Roga Shri Dhanwantary Ayurvedic college and hospital Sector 46 B Chandigarh
Chandigarh CHANDIGARH 160047 India
Phone
9447767909
Fax
Email
archanas875@gmail.com
Details of Contact Person Public Query
Name
Dr Monika Kaushik
Designation
PG scholar
Affiliation
Shri Dhanwantary Ayurvedic College and Hospital
Address
room no 205 A Department of prasuti evam stree roga Shri Dhanwantary Ayurvedic College and hospital Sector 46 B Chandigarh
Chandigarh CHANDIGARH 160047 India
Phone
9599563553
Fax
Email
kmonika1595@gmail.com
Source of Monetary or Material Support
OPD of PTSR Department and pharmacy of Shri Dhanwantary Ayurvedic Hospital
Primary Sponsor
Name
Dr Monika Kaushik
Address
Shri Dhanwantary Ayurvedic College and Hospital Sector 46 B Chandigarh
Type of Sponsor
Other [PG Scholar of PTSR Department]
Details of Secondary Sponsor
Name
Address
Shri Dhanwantary Ayurvedic College andHospital
sector 46 b Chandigarh
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Monika Kaushik
Shri Dhanwantary Ayurvedic College and Hospital
room no 105 opd of prasuti tantra evum stree roga Chandigarh CHANDIGARH
9599563553
kmonika1595@gmail.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
Institutional Ethics Committee Shri Dhanwantary Ayurvedic college and Hospital Sector 46 B Chandigarh
(1) Medicine Name: vachadi gana ghan vati versus lasunadi vati, Reference: Ashtang hridya sutra 15/35 for vachadi gana and kshaya roga chikitsa visuchika upchar jivnam jeevak vaidya for lasunadi vati, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: -
Inclusion Criteria
Age From
18.00 Year(s)
Age To
40.00 Year(s)
Gender
Female
Details
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
ExclusionCriteria
Details
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
Method of Generating Random Sequence
Coin toss, Lottery, toss of dice, shuffling cards etc
Method of Concealment
An Open list of random numbers
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Reduction in inter menstrual interval and Reduction in body weight
at baseline and after 90 days
Secondary Outcome
Outcome
TimePoints
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
Target Sample Size
Total Sample Size="72" Sample Size from India="72" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
Phase 2
Date of First Enrollment (India)
30/05/2024
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="0" Months="4" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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.