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CTRI Number  CTRI/2025/07/090578 [Registered on: 09/07/2025] Trial Registered Prospectively
Last Modified On: 08/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Compare and evaluate the efficacy of Bala taila Matra basti with Shatavari kalpa and Chandraprabha vati in management of Menopausal Syndrome. 
Scientific Title of Study   Clinical study to compare and evaluate the efficacy of Bala taila Matra basti with Shatavrai kalpa and Chandraprabha vati to Improve MRS scale in 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 Seema yadav 
Designation  Ph D Scholar 
Affiliation  FIMS,SGT university Gurgaon 
Address  FIMS, Department of PTSR SGT university Gurugram

Gurgaon
HARYANA
122505
India 
Phone  8295815981  
Fax    
Email  drseemachetan@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jyoti Kumbar 
Designation  Professor and HOD 
Affiliation  FIMS,SGT university Gurugram 
Address  FIMS, Department of PTSR SGT University , Gurugram

Gurgaon
HARYANA
122505
India 
Phone  9482628541  
Fax    
Email  jyoti.fims@sgtuniversity.org  
 
Details of Contact Person
Public Query  
Name  Dr Seema Yadav 
Designation  PhD Scholar 
Affiliation  FIMS,SGT university Gurugram 
Address  FIMS, Department of PTSR SGT university , Gurugram

Gurgaon
HARYANA
122505
India 
Phone  8295815981  
Fax    
Email  drseemachetan@gmail.com  
 
Source of Monetary or Material Support  
SGT University Chandu Bhudhera , Gurugram India pin -122505  
 
Primary Sponsor  
Name  SGT university Gurugram 
Address  Chandu Budhera, Gurugram India Pin-122505 
Type of Sponsor  Private medical college 
 
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 Seema yadav  SGT Ayurveda hospital  SGT ayurvedic Hospital PTSR OPD room no-05Chandu Bhudera, Badli road, Gurugram
Gurgaon
HARYANA 		 08295815981

drseemachetan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N951||Menopausal and female climactericstates. Ayurveda Condition: RAJONASAH (KEVALAVATA), (2) ICD-10 Condition:N951||Menopausal and female climactericstates. Ayurveda Condition: RAJONASAH (KEVALAVATA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-mAtrAbastiH, मात्राबस्तिः (Procedure Reference: charak samhita, Procedure details: Once per day)
(1) Medicine Name: Bala taila, Reference: shastrayoga, Route: Rectal, Dosage Form: Taila, Dose: 80(ml), Frequency: od, Duration: 7 Days
2Intervention ArmDrugClassical(1) Medicine Name: shatavari kalpa, Reference: shushruta samhita, Route: Oral, Dosage Form: Khanda /Granules, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -milk), Additional Information: - with milk
3Comparator ArmDrugClassical(1) Medicine Name: chandraprabha vati, Reference: bhaisjya ratnavali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 37 Days, anupAna/sahapAna: Yes(details: -water), Additional Information: vati to be taken with normal water
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  55.00 Year(s)
Gender  Female 
Details  1. Age between 40-55years who have attained menopause
2. Women who is having clinical features of Menopausal syndrome
3. Patient fit for Basti procedure.
 
 
ExclusionCriteria 
Details  1)age less than 40years and more than 55years
2) Patient with pre existing medical condition like DM, HTN 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
improvement in MRS scale  improvement in MRS scale before and after treatment 
 
Secondary Outcome  
Outcome  TimePoints 
Sr Estrdiaol
Bone mass density 		 before and after treatment  
 
Target Sample Size   Total Sample Size="96"
Sample Size from India="96" 
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)   01/08/2025 
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="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   In this present study patients will be recruited in two groups. One group is administered with Bala taila matra basti 80 ml for 7 days followed by Shatavari Kalpa 5gm twice a day . Second group is administered with Chandraprabha Vati 250mgm twice daily for 37 days. Both Groups are assessed for Improvement in 11 criteria of MRS( Menopausal rating scale). 
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