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CTRI Number  CTRI/2024/08/071979 [Registered on: 06/08/2024] Trial Registered Prospectively
Last Modified On: 12/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Ayurvedic management of symptoms before and during menopause 
Scientific Title of Study   A Comparative Clinical Study to evaluate the efficacy of Sapthavimshathi Guggulu and Soubhagya Vati after Virechana in Perimenopausal syndrome 
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 Hasinabegum P 
Designation  PG Scholar 
Affiliation  Government Ayurveda Medical College and Hospital Mysore 
Address  Post Graduate Department of Kayachikitsa Government Ayurveda Medical College and Hospital Vishweshwaraiah Circle Devraj Mohalla Mysore Karnataka 570001 India

Mysore
KARNATAKA
570001
India 
Phone  9380327391  
Fax    
Email  hasina2410@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mythrey R C 
Designation  Professor and Head of the Department 
Affiliation  Government Ayurveda Medical College and Hospital Mysore 
Address  Post Graduate Department of Kayachikitsa Government Ayurveda Medical College and Hospital Mysore Vishweshwaraiah circle Devraj Mohalla Mysore Karnataka India 570001

Mysore
KARNATAKA
570001
India 
Phone  8618570803  
Fax    
Email  mythreyrc@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Hasinabegum P 
Designation  PG Scholar 
Affiliation  Government Ayurveda Medical College and Hospital Mysore 
Address  Post Graduate Department of Kayachikitsa Government Ayurveda Medical College and Hospital Vishweshwaraiah Circle Devraj Mohalla Mysore Karnataka 570001 India

Mysore
KARNATAKA
570001
India 
Phone  9380327391  
Fax    
Email  hasina2410@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurveda Medical College and Hospital Mysore Karnataka India 570001 
 
Primary Sponsor  
Name  Dr Hasinabegum P 
Address  Post Graduate Department of Kayachikitsa Government Ayurveda Medical College and Hospital Mysore Karnataka 570001 India 
Type of Sponsor  Other [[Self]] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Hasinabegum P  Government Ayurveda Medical College and Hospital  Room number 10 kayachikitsa OPD and IP Wards of Government Ayurveda Medical College and Hospital Mysore Karnataka 570001 India
Mysore
KARNATAKA 
9380327391

hasina2410@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Government Ayurveda Medical College Mysore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N959||Unspecified menopausal and perimenopausal disorder. Ayurveda Condition: VARDHAKYAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: SAPTHAVIMSHATI GUGGULU, Reference: Bhaishajya Ratnavali , Route: Oral, Dosage Form: Guggulu , Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Ushnajala), Additional Information: -
(2) Medicine Name: SOUBHAGYA VATI, Reference: Bhaishajya Ratnavali Chapter 5, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Ushnajala), Additional Information: -
2Intervention ArmProcedure-virecana-karma, विरेचन-कर्म (Procedure Reference: CHARAKA SAMHITA, Procedure details: Deepana Pachana with Chitrakadi Vati 250mg with luke warm water before food till the appearance of Nirama Lakshanas. Shodhananga Snehapana will be administered in Aarohana Krama with Kalyanaka Ghritha from the day of Nirama Lakshanas till Samyak Snigdha Lakshanas are seen. Sarvadaihika Abhyanga with Ksheerabala Taila followed by Nadi Sweda will be done for 3 days. For the purpose of Virechana Trivrut Lehya will be administered after assessing the Koshta. Samsarjana Krama will be followed according to the type of Shuddhi )
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Female subjects of age group 40 to 50 years
Subjects diagnosed based on diagnostic criteria 
 
ExclusionCriteria 
Details  Subjects who have attained surgical menopause will be excluded
Subjects who are having uncontrolled diabetes and hypertension will be excluded
Subjects who are suffering from any other systemic disorders which interfere with the course of disease and treatment will be excluded
Subjects who are unfit for Virechana will be excluded 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Assessing relief in the symptoms of Perimenopausal syndrome like hot flushes,sweating,sleep problems,muscle and joint pain.

 
at baseline, after samsarjana krama(mid assessment) and 28th day after samsarjana krama(post assessment)
 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the efficacy of Sapthavimshathi Guggulu and Soubhagya Vati after Virechana in Perimenopausal syndrome by assessing relieving of symptoms through Green Climacteric Scale  40th day 
To compare the efficacy of Sapthavimshathi Guggulu and Soubhagya Vati after Virechana in Perimenopausal syndrome by assessing relieving of symptoms through Green Climacteric Scale  After Virechna
After Samsarjana krama
After Completion of Intervention 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 3 
Date of First Enrollment (India)   20/08/2024 
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="1"
Months="0"
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  
Menopause means permanent cessation of menstruation at the end of reproductive life due to loss of ovarian follicular activity. Perimenopause is the part of the climacteric where the menstrual cycle is likely to be irregular  It is associated with erratic fluctuation in reproductive hormone levels often leading to vasomotor symptoms change in mood or cognition and sexual dysfunction The prevalence of peri menopausal syndrome is 1.79% in 40 to 45 years 7.98% in 45-50 years In Ayurveda the time of Rajonivrutti is said to be 50 years  The stage of Parihani (from 41 to 70 years) which comes under classification of age according to Sushrutha can be considered as perimenopausal age During this phase Sapthadhatu starts to debilitate This is the stepping stage from Madhyama Avastha to Vruddha Avastha  This phase is the transition from Pitta Pradhana Avastha to the Vata Pradhana Avastha Both Shareerika and Maanasika doshas are affected producing symptoms like Alasya Shrama Dourbalya (physical exhaustion)  Nidranasha (sleep problems)  Klama The hormone replacement therapy is indicated in the menopausal women to overcome the short term and long term consequences of estrogen deficiency  But estrogen hormone in long term usage causes endometrial and breast cancer coronary heart disease  venous thromboembolic disease  dementia and Alzheimer disease So non hormonal way of approach through ayurveda can be a priority  Hence the study to evaluate the effect of Saptavimshati Guggulu and Soubhagya Vati after Virechana to manage both Shareerika and Manasika doshic vitiation in perimenopausal syndrome will be undertaken
 
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