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CTRI Number  CTRI/2011/06/001804 [Registered on: 13/06/2011] Trial Registered Retrospectively
Last Modified On: 07/02/2013
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A double blind placebo controlled clinical trial to evaluate the efficacy and safety of Shatavari in Menstrual irregularity 
Scientific Title of Study   A double blind placebo controlled clinical trial to evaluate the efficacy and safety of Shatavari in Menstrual irregularity 
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 Sharda More 
Designation  Lecturer, Department of Agad Tantra 
Affiliation   
Address  Shuvdeep Ayurved Medical college & Hospital, Indore

Indore
MADHYA PRADESH
452020
India 
Phone  08022169999  
Fax    
Email  drshardamore@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sharda More 
Designation  Lecturer, Department of Agad Tantra 
Affiliation   
Address  Shuvdeep Ayurved Medical college & Hospital, Indore

Indore
MADHYA PRADESH
452020
India 
Phone    
Fax    
Email  drshardamore@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sharda More 
Designation  Lecturer, Department of Agad Tantra 
Affiliation   
Address  Shuvdeep Ayurved Medical college & Hospital, Indore

Indore
MADHYA PRADESH
452020
India 
Phone    
Fax    
Email  drshardamore@gmail.com  
 
Source of Monetary or Material Support  
The Himalaya Drug Company 
 
Primary Sponsor  
Name  The Himalaya Drug Company 
Address  The Himalaya Drug Company Makali, Bangalore 562 123 
Type of Sponsor  Pharmaceutical industry-Global 
 
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 Patki  Shuvdeep Ayurved Medical College & Hospital  Shuvdeep Ayurved Medical College & Hospital, Khandwa Road, Indore 452020
Indore
MADHYA PRADESH 		 08022169999

dr.patki@himalayahealthcare.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee (EC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Menstrual irregularity,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo  Dose - 1 caplet of Placebothrice daily Duration of treatment - 3 months Mode of administration - oral 
Intervention  Shatavari  Dose - 1 caplet of Shatavari thrice daily Duration of treatment - 3 months Mode of administration - oral 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  70.00 Year(s)
Gender  Female 
Details  Females above the age of 45 with postmenopausal symptoms like hot flashes, night sweats, dry itchy skin, sleep disturbances, irritability, joint pain, anxiety or depression will be included in the study. 
 
ExclusionCriteria 
Details  Subjects suffering from serious life threatening disorders or participated in a similar study within past 1 month will be excluded from the study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment    
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Improvement in post menopausal symptoms.   3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of long term safety of Shatavari caplet.  3 months 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   07/10/2010 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not applicable 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   Females above the age of 45 with postmenopausal symptoms like hot flashes, night sweats, dry itchy skin, sleep disturbances, irritability, joint pain, anxiety or depression and meeting the other inclusion/exclusion criteria will be eligible to participate in the study. Subjects will be given 1 caplet thrice daily of Shatavari caplet or placebo , based on the randomization for 3 months.

Subjective and objective evaluation will be done. Assessment will be done on entry, at the end of 1stnd month and at the end of 3rd month. Adverse effects as volunteered by the patients will be noted in the CRFs. Information on each patient will be collected from their history, physical examination and laboratory investigations, and will be recorded on the Case Report Form.

 
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