FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/07/090150 [Registered on: 03/07/2025] Trial Registered Prospectively
Last Modified On: 02/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   A Clinical study to evaluate the efficacy of tablet bramhi you with bruhat shatavari ghee and tablet manasamitra with bruhat shatavari ghee orally in the management of perimenopausal syndrome  
Scientific Title of Study   An open label double arm randomised clinical study to evaluate the efficacy of bramhi vati with bruhat shatavari ghrita and manasamitra vati with bruhat shatavari ghrita orally in the management of perimenopausal syndrome  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Not applicable   NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pratiksha Mane  
Designation  Pg Scholar  
Affiliation  Sri kalbyaraveshwara swamy ayurvedic medical College hospital and research centre  
Address  Room no 209 Dept of prasooti tantra evum streeroga Sri kalbyaraveshwara swamy ayurvedic medical College hospital and research centre vijayanagar Banglore
Room no 209 Dept of prasooti tantra evum streeroga Sri kalbyaraveshwara swamy ayurvedic medical College hospital and research centre vijayanagar Banglore
Bangalore
KARNATAKA
560104
India 
Phone  7057218184  
Fax    
Email  Pratikshamane2@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anupama V 
Designation  Professor and HOD 
Affiliation  Sri kalbyaraveshwara swamy ayurvedic medical College hospital and research centre  
Address  Room no 209 Dept of prasooti tantra evum streeroga sri kalbyaraveshwara swamy ayurvedic medical College hospital and research centre vijayanagar Banglore
Room no 209 Dept of prasooti tantra evum streeroga Sri kalbyaraveshwara swamy ayurvedic medical College hospital and research centre vijayanagar Banglore
Bangalore
KARNATAKA
560104
India 
Phone  9845442660  
Fax    
Email  dr.anupama.v@Gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Anupama V 
Designation  Professor and HOD 
Affiliation  Sri kalbyaraveshwara swamy ayurvedic medical College hospital and research centre  
Address  Room no 209 Dept of prasooti tantra evum streeroga Sri kalbyaraveshwara swamy ayurvedic medical College hospital and research centre vijayanagar Banglore
Room no 209 Dept of prasooti tantra evum streeroga Sri kalbyaraveshwara swamy ayurvedic medical College hospital and research centre vijayanagar Banglore
Bangalore
KARNATAKA
560104
India 
Phone  9845442660  
Fax    
Email  dr.anupama.v@Gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Dr Pratiksha Mane  
Address  Room no 209 Dept of prasooti tantra evum stree roga Sri kalbyaraveshwara swamy ayurvedic medical College hospital and research centre vijayanagar Banglore  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  Not applicable  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kiran M Goud   Sri kalbyaraveshwara swamy ayurvedic medical College   Room no 209 Department of Prasooti tantra evum stree roga 10 pipeline road RPC layout Vijayanagar Bangalore 560104
Bangalore
KARNATAKA 		 9845109556

kiranmgoud@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri kalabhyaraweshwara ayurvedic medical College hospital and research centre 10 pipeline road RPC layout Vijayanagar Bangalore 560104  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: ARTAVADOSHAH/ARTAVADUSHTIH/RAJODOSHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Bramhi Vati , Reference: Ayurveda sara sangraha , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 180(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -water ), Additional Information: -
(2) Medicine Name: Bruhat shatavari ghrita , Reference: Charaka chikistasthan chapter 30, Route: Oral, Dosage Form: Ghrita, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -milk ), Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Manasamitra vati , Reference: Sahasrayogam , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 100(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -water ), Additional Information: -
(2) Medicine Name: Bruhat shatavari ghrita , Reference: Charaka chikistasthan chapter 30 , Route: Oral, Dosage Form: Ghrita, Dose: 6(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -milk ), Additional Information: -
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  55.00 Year(s)
Gender  Female 
Details  Subjects fulfilling diagnostic criteria.
Subjects with age group of 40 – 55 years
Subjects with symptoms of Perimenopausal Syndrome
Both Married and Unmarried
 
 
ExclusionCriteria 
Details  Subjects who had undergone hysterectomy
Subjects with history of systemic disorders which interfere with the course of treatment
Women with psychological disorders
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate and compare the efficacy of the bramhi Vati with bruhat shatavari ghrita and manasamitra vati with bruhat shatavari ghrita orally in the management of symptoms of perimenopausal syndrome   One and half year  
 
Secondary Outcome  
Outcome  TimePoints 
Nil   Nil 
 
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   N/A 
Date of First Enrollment (India)   18/09/2025 
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="6"
Days="5" 
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   Perimenopause (also referred to as the menopause transition) is when body starts transitioning to menopause. During this transition Body begin producing less hormones, causing menstrual cycle to become irregular. Once enter perimenopause, estrogen levels start to decrease. Due to decreased level of estrogen psychological changes like Mood Swings, Hot flushes &
Sweating, Irritability, Anxiety happened in body. So in this condition, Manasamitra vati mentioned in Sahasrayogam gutika prakarana is said to have action on manovaha srotas and
Bramhi vati mentioned in Ayurveda sara sangraha gutika prakarana is said to have action on Manovaha srotas as well as impact on memory. Bruhat shatavari ghrita mentioned in Charaka
Samhita chikista sthana also has effect on vataja pittaja vyadhi and reproductive system.
Hence the present study will be undertaken to evaluate and compare the effect of Manasamitra vati and Bramhi vati along with Bruhat shatavari ghrita in Perimenopausal syndrome.

 
Close