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CTRI Number  CTRI/2025/07/090812 [Registered on: 14/07/2025] Trial Registered Prospectively
Last Modified On: 06/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To Study the Efficacy of Bruhata Shatavari Ghrita in the Management of Rajonivrutti with Special Reference to Peri-Menopausal Syndrome  
Scientific Title of Study   OPEN LABELLED RANDOMIZED CONTROLLED TRIAL TO EVALUATE THE EFFICACY OF BRUHATA SHATAVARI GHRITA IN THE MANAGEMENT OF RAJONIVRUTTI W.S.R TO PERI MENOPAUSAL 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 Snehal Suryakant Panjarale 
Designation  PG Scholor  
Affiliation  SST Ayurved Mahavidyalaya, Sangamner 
Address  opd no 1 prasutitantra and strirog department ground floor sst ayurved college Front of prasad hotel, pune-nashik highway, Sangamner Ahmadnagar MAHARASHTRA 422605 India

Ahmadnagar
MAHARASHTRA
422605
India 
Phone  9423497110  
Fax    
Email  snehal.panjarale@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Snehal Suryakant Panjarale 
Designation  PG Scholor  
Affiliation  SST Ayurved Mahavidyalaya, Sangamner 
Address  opd no 1 prasutitantra and strirog department ground floor sst ayurved college Front of prasad hotel, pune-nashik highway, Sangamner Ahmadnagar MAHARASHTRA 422605 India

Ahmadnagar
MAHARASHTRA
422605
India 
Phone  9423497110  
Fax    
Email  snehal.panjarale@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Amit Shinde  
Designation  HOD Striroga Prasuti Tantra Department  
Affiliation  SST Ayurved Mahavidhyala , Sangamner 
Address  OPD no 1 Prasuti Tantra and Stri Roga OPD Ground Floor SST Ayurved Medical college Sangamner Dist Ahmadnagar Ahmadnagar MAHARASHTRA 422605 India

Ahmadnagar
MAHARASHTRA
422605
India 
Phone  09881303593  
Fax    
Email  amitshinde112@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Snehal Suryakant Panjarale 
Address  sangam sevabhavi trust ayurved mahavidyalaya sangamner ghulewadi dist ahmadnagar 422605 
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 Snehal Suryakant Panjarale  SST Ayurved Mahavidyalaya, Sangamner  OPD no 1 Prasuti Tantra and Stri Roga OPD Ground Floor SST Ayurved Medical college Sangamner Dist Ahmadnagar Ahmadnagar MAHARASHTRA 422605 India
Ahmadnagar
MAHARASHTRA 		 9423497110

snehal.panjarale@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N958||Other specified menopausal and perimenopausal disorders. Ayurveda Condition: RAJONASAH (KEVALAVATA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: BRUHATA SHATAVARI GHRITA, Reference: Charak Samhita, Route: Oral, Dosage Form: Ghrita, Dose: 20(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -warm water), Additional Information: -
2Comparator Arm (Non Ayurveda)-Tab PremarinEstrogen therapy Short term Hormone Replacement Therapy[HRT] Tab. Premarin [0.625 mg] 1 tablet is taken orallay as bed time from 1st to 20th day of a month for 3 months. If patient is premenopausal with irregular bleeding will be given p4 to p24 menstrual cycle
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  Appearance of peri-menopausal syndrome. i.e.
Hot flushes ( Daha Prachiti )
Excessive sweating (Prabhuta Swedata)
Backache (Katishoola)
Sleep disturbances ( Asamyaka Nidra )
Dryness of vagina12 ( Yonishushkata )
 
 
ExclusionCriteria 
Details  Diagnosed patients of Diabetes and Hypertension.
Pre-existing Psychological disorder or any systemic disease. uterine prolapsed cancer.
Patients who had undergone hysterectomy.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
to relief of peri-menopausal syndrome  to relief of peri-menopausal syndrome in 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
bruhata shatavari ghrita is significantly effective in management of Rajanivrutti w.s.r. to Peri-menopausal syndronme  3 months 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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/ Phase 4 
Date of First Enrollment (India)   29/07/2025 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   it is a open labelled randomized controlled trial to evaluate the efficacy of bruhata shatavari ghrita in the management of rajonivrutti with respect to peri-menopausal syndrome in 40 to 50 years old female 
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