FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2014/06/004709 [Registered on: 27/06/2014] Trial Registered Prospectively
Last Modified On: 19/10/2015
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Siddha 
Study Design  Single Arm Study 
Public Title of Study   A trial drug for Polycystic Ovarian disease 
Scientific Title of Study   A pilot study of Karbhakandhi ennai for the treatment of PCOS (Sinaipaineerkatti) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SKeerthana 
Designation  PG Scholar 
Affiliation  National Institute Of Siddha 
Address  Department of kuzhandhai maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai-47

Chennai
TAMIL NADU
600047
India 
Phone    
Fax    
Email  sk.keerthana@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  SKeerthana 
Designation  PG Scholar 
Affiliation  National Institute Of Siddha 
Address  Department of kuzhandhai maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai-47

Chennai
TAMIL NADU
600047
India 
Phone    
Fax    
Email  sk.keerthana@gmail.com  
 
Details of Contact Person
Public Query  
Name  MMeenakshi Sundaram 
Designation  Associate Professor, NIS 
Affiliation  National Institute Of Siddha 
Address  Associate professor Department of kuzhandhai maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai-47

Chennai
TAMIL NADU
600047
India 
Phone    
Fax    
Email  mmssiddha@gmail.com  
 
Source of Monetary or Material Support  
Self 
 
Primary Sponsor  
Name  National Institute of Siddha 
Address  Department of kuzhandhai maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai-47 
Type of Sponsor  Research institution and hospital 
 
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 
SKeerthana  National Institute of Siddha  Ayothidass Pandithar Hospital Department of kuzhandhai maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai-47
Chennai
TAMIL NADU 		 9962927684

sk.keerthana@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instituitional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Irregular Menstrual cycles,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Karbagandhi Ennai Internal for Sinaipaineerkatti   Karbagandhi Ennai is a herbomineral drug given 3-5 drops OD dose for three months. 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  •Irregular menstrual cycle: Eight or fewer menstrual cycles in the past year or intermenstrual periods of 45 days or longer.
•Patients having polycystic ovary on ultrasound should either have 12 or more follicles measuring 2-9 mm in diameter, or have an increased ovarian volume of 10 CC or greater
•Patient willing for Ultrasound abdomen and blood investigations.
•Patient willing to sign the informed consent 
 
ExclusionCriteria 
Details  •Presence of any pelvic pathology such as chronic pelvic infection, Pelvic endometriosis, Adenomyosis, Uterine fibroid, Endometrial Polyp.
•Presence of secondary endocrine disorder such as hyperprolactinaemia, thyroid dysfunction.
•Patient using oral contraceptives or use of fertility drugs within 6 months
•Presence of any associated severe systemic illness. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
•Normal appearing of ovary confirmed by TV USG or Confirming of normal follicles being formed and ruptured through folliculogram.
•Establishing regularization of menstrual cycle. 		 6-9 months 
 
Secondary Outcome  
Outcome  TimePoints 
•Enhancing weight reduction with a BMI 30.
•Reducing elevated hormone levels like testosterone and DHEAS. 		 Follow-up of the patients for three menstrual cycles 
•Enhancing weight reduction with a BMI 30.
•Reducing elevated hormone levels like testosterone and DHEAS. 		 Follow-up of the patients for three menstrual cycles 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   14/07/2014 
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="0"
Months="11"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   After the trial drug study 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

This is a single arm open clinical trial to find out the therapeutic effect of Karpagandhi ennai (Internal). The trial drug is a combination of herbomineral drugs from the Siddha Text book Anubhava Siddha Vaidhya Muraigal (Author Balaraamayya )for the namagement of Sinaipaineerkatti (PCOS) in women. The constituents of the trial drug are Gandhagam (Sulphur), Poondu (Allium sativum), Gingelly oil (Seasamum indicum).  The internal drug will be issued in oil form at a dosage of 5 drops once a day with half-baked egg yolk for 10 days thereafter the drug will be stopped for next 10 days and restarted for 10 days.  Likewise drug will be given for 30 days for a patient. The clinical assessment and laboratory investigations will be recorded before and after the treatment period.  All the trial related data will be recorded, analysed statistically and the research reports will be published. 

 
Close