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CTRI Number  CTRI/2025/08/093253 [Registered on: 19/08/2025] Trial Registered Prospectively
Last Modified On: 18/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   How Talamuli powder mixed with cows milk help in reducing symptoms during perimenopause. 
Scientific Title of Study   Effect of Talamuli (Curculigo orchioides Gaertn.) choorna with Go ksheera (Cow’s milk) in Perimenopausal symptoms. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  RINSHA SHAREEF 
Designation  PG Scholar 
Affiliation  Government Ayurveda College Tripunithura 
Address  Department of Dravyaguna Vigyana Government Ayurveda College Tripunithura Ernakulam Kerala 682301

Ernakulam
KERALA
682301
India 
Phone  9539387227  
Fax    
Email  rinshashareef1994@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr SHINCYMOL V V 
Designation  Associate Professor 
Affiliation  Government Ayurveda College Tripunithura 
Address  Department of Dravyaguna Vigyana Government Ayurveda College Tripunithura Ernakulam Kerala 682301

Ernakulam
KERALA
682301
India 
Phone  9947012863  
Fax    
Email  vvshincymol@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr SHINCYMOL V V 
Designation  Associate Professor 
Affiliation  Government Ayurveda College Tripunithura 
Address  Department of Dravyaguna Vigyana Government Ayurveda College Tripunithura Ernakulam Kerala 682301

Ernakulam
KERALA
682301
India 
Phone  09947012863  
Fax    
Email  vvshincymol@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurveda College Tripunithura 
 
Primary Sponsor  
Name  Rinsha Shareef 
Address  Department of Dravyaguna Vigyana Government Ayurveda College Tripunithura Ernakulam Kerala 682301 
Type of Sponsor  Other [PG Scholar Government Ayurveda College Tripunithura] 
 
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 SHINCYMOL V V  Government Ayurveda College Tripunithura  Department of Dravyaguna Vigyana Government Ayurveda College Tripunithura Ernakulam Kerala 682301
Ernakulam
KERALA 		 09947012863

vvshincymol@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE GOVERNMENT AYURVEDA COLLEGE TRIPUNITHURA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E35||Disorders of endocrine glands in diseases classified elsewhere. Ayurveda Condition: RAJONASAH (KEVALAVATA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Talamuli choorna with Go ksheera, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Go ksheera), Additional Information: -NIL
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  55.00 Year(s)
Gender  Female 
Details  Females diagnosed to have perimenopausal symptoms as per the Greene Climacteric Scale.
Greene Climacteric scale score above 30.
Patients willing to give written consent. 
 
ExclusionCriteria 
Details  Surgical menopause.
Any known case of malignancy.
Psychiatric disorders.
Pregnancy.
Uncontrolled chronic and systemic illness. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Changes in the level of symptoms are assessed as outcome variables as per the Greene Climacteric Scale.
Psychological symptoms
Somatic symptoms
Vasomotor symptoms  		 Changes in the level of symptoms are assessed as outcome variables as per the Greene Climacteric Scale before treatment(0th day), during treatment for 30 days(31st day) and after follow up for 30 days without medication (61st day)  
 
Secondary Outcome  
Outcome  TimePoints 
Pharmacognostical, phytochemical, HPTLC & Ayurvedic parameters(Rasa, Guna, Virya & Vipaka) of Talamuli(Curculigo orchioides Gaertn.)Rhizome & Talamuli choorna.  15 days before commencement of the study. 
 
Target Sample Size   Total Sample Size="27"
Sample Size from India="27" 
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/ Phase 3 
Date of First Enrollment (India)   09/09/2025 
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="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   The above study deals with the effect of Talamuli choorna with Go ksheera in managing Perimenopausal symptoms which is assessed as per the Greene Climacteric Scale. The study also aims to evaluate the pharmacognostical, phytochemical, HPTLC and Ayurvedic parameters of Talamuli rhizome and Talamuli choorna. Patients in the 40-55 years coming under the inclusion ciriteria will be administered Talamuli choorna orally in the dose of 3 gm with125 ml cow’s milk twice daily(7 am and 7 pm) before food for a duration of 30 days.Assessment will be done pre and post treatment based on the Greene Climacteric Scale.  
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