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CTRI Number  CTRI/2022/06/043224 [Registered on: 13/06/2022] Trial Registered Prospectively
Last Modified On: 12/07/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Siddha 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study on Venpoosani nei and Thiriphala chooranam for the manageent of Leucorrhoea(White discharge) 
Scientific Title of Study   AN OPEN RANDOMISED DOUBLE ARM CLINICAL TRIAL TO EVALUATE AND COMPARE THE EFFICACY OF SIDDHA HERBAL FORMULATIONS “VENPOOSANI NEI” (INTERNAL) VERSUS “VENPOOSANI NEI (internal) WITH THIRIPHALA CHOORNAM WASH (external) IN “VELLAI NOI” FOR FEMALE PATIENTS ATTENDING SCRI - CHENNAI 
Trial Acronym  VPNTPV 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr T Kavitha 
Designation  Research Officer Siddha 
Affiliation  Siddha Central Research Institute- Central Council for Research in Siddha 
Address  A room opposite to left in 3rd floor, Department of clinical research, Siddha Central Research Institute, Anna Hospital campus, Arumbakkam, Chennai-106, Tamil Nadu, India.
No:9, K.C.Garden, 3rd street, Peravallur, Chennai-600082.
Chennai
TAMIL NADU
600106
India 
Phone  8072696654  
Fax    
Email  logakavitha1980@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr P Sathiyarajeswaran 
Designation  Director Incharge 
Affiliation  Siddha Central Research Institute 
Address  Siddha Central Research Institute, Anna Hospital Campus, Arumbakkam, Chennai 600106

Chennai
TAMIL NADU
600106
India 
Phone  9443579540  
Fax    
Email  crisiddha@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr P Sathiyarajeswaran 
Designation  Director Incharge 
Affiliation  Siddha Central Research Institute 
Address  Siddha Central Research Institute, Anna Hospital Campus, Arumbakkam, Chennai 600106

Chennai
TAMIL NADU
600106
India 
Phone  9443579540  
Fax    
Email  crisiddha@gmail.com  
 
Source of Monetary or Material Support  
Central Council for Research in Siddha 
 
Primary Sponsor  
Name  Central Council for Research in Siddha 
Address  Central Council Research in Siddha, Anna Hospital Campus, Arumbakkam, Chennai-106. 
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 
Dr T Kavitha  Siddha Central Research Institute  Room no 1, Reproductive and child health Division, Department of Clinical Research, Siddha Central Research Institute, Arumbakkam, Chennai 600106.
Chennai
TAMIL NADU 		 8072696654

logakavitha1980@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N889||Noninflammatory disorder of cervixuteri, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Arm :1 : Mono therapy with Venpoosani nei (internal)  7.5 ml, Two times a day after food - Duration-40 days 
Comparator Agent  Arm: 2 : Combination therapy with Venpoosani nei (internal) and Thiripala choornam (external)   7.5 ml, Two times a day after food, 5gm Thiriphala chooranam for decoction (External wash) Duration: 40 days.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  1 Age – 18 to 50 Years
2 Gender – Married Female
3 Thick whitish or yellowish or greenish discharge from vagina with foul smell
4 Itching and burning sensation in vulva
5 Vaginal swab test positive for micro-organism
6 Dysuria
7 Lower abdominal pain
8 Pain in lumbar region
 
 
ExclusionCriteria 
Details  1.White discharge with bleeding
2.Ovarian cyst or tumor, prolapse
3.Pregnancy and lactation
4.Diabetes
5.Physiological vaginal discharge
6.Use of antibiotics or local vaginal formulation within the previous month
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Trial is to show vaginal swab negative for micro-organism  After 40 days 
 
Secondary Outcome  
Outcome  TimePoints 
1.Reduction of signs and symptoms of vellai noi (leucorrhea) – (Severity score)
2.To assess whether administration of venpoosani nei alter the lipid levels by measuring lipid profile, before and after treatment.
 		 After 40 days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   09/07/2022 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This is an interventional trial to evaluate and compare the efficacy of two Siddha formulations. Vellai noi is compared with leucorrhoea in modern medicine. Abnormal genital discharge (Leucorrhoea) is quit a frequent complaint of women in day today life. If leucorrhoea is untreated it leads to complications of chronic abdominal pain, recurrent infections, pelvic inflammatory diseases. Primary objective of the trial is to evaluate and compare the efficacy of Siddha herbal drug "Venpoosani Nei" (Internal ) and Venpoosani (Internal) with Thiripala choornam wash(External) in female Vellai noi. Primary objective will be determined by vaginal smear test. Secondary objective of the trial is to compare the improvement  in signs and symptoms of trial participants using severity score and to determined whether administration of venpoosani nei alters the lipid levels. Venpoosani nei contains drugs having anti microbial, anti oxidant, anti inflammatory and anti diuretic which is essential to cure leucorrhoea-Vellai noi. In Siddha meteria medica, Kadukkai(Treminalia chebulla) , Nellikkai (Emblica officinalis), Thandrikkai (Terminalia bellerica) are indicated for Vellai noi. 
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