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CTRI Number  CTRI/2022/11/047334 [Registered on: 15/11/2022] Trial Registered Prospectively
Last Modified On: 15/11/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Siddha 
Study Design  Other 
Public Title of Study   OPEN CLINICAL EVALUATION OF SIDDHA MEDICINE NAGA SANGU PARPAM IN KABAYONI ROGAM ( VULVO VAGINAL CANDIDIASIS 
Scientific Title of Study   PHASE 2 NON-RANDOMISED OPEN CLINICAL EVALUATION OF SIDDHA MEDICINE NAGA SANGU PARPAM IN KABAYONI ROGAM ( VULVO VAGINAL CANDIDIASIS) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  AMARAVATHY S 
Designation  PG SCHOLAR 
Affiliation  Government siddha medical College 
Address  POST GRADUATE DEPARTMENT OF POTHU MARUTHUVAM GOVERNMENT SIDDHA MEDICAL COLLEGE ARUMBAKKAM CHENNAI Chennai TAMIL NADU 600 106 India
POST GRADUATE DEPARTMENT OF POTHU MARUTHUVAM GOVERNMENT SIDDHA MEDICAL COLLEGE ARUMBAKKAM CHENNAI
Chennai
TAMIL NADU
600 106
India 
Phone  8072768456  
Fax    
Email  amaravathy184@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr N ANBU 
Designation  HOD and PROFESSOR 
Affiliation  Government siddha medical College 
Address  POST GRADUATE DEPARTMENT OF POTHU MARUTHUVAM GOVERNMENT SIDDHA MEDICAL COLLEGE ARUMBAKKAM CHENNAI
POST GRADUATE DEPARTMENT OF POTHU MARUTHUVAM GOVERNMENT SIDDHA MEDICAL COLLEGE ARUMBAKKAM CHENNAI
Chennai
TAMIL NADU
600 106
India 
Phone  9443279412  
Fax    
Email  nanbu.sumi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  AMARAVATHY S 
Designation  PG SCHOLAR 
Affiliation  Government Siddha medical College 
Address  POST GRADUATE DEPARTMENT OF POTHU MARUTHUVAM GOVERNMENT SIDDHA MEDICAL COLLEGE ARUMBAKKAM CHENNAI
POST GRADUATE DEPARTMENT OF POTHU MARUTHUVAM GOVERNMENT SIDDHA MEDICAL COLLEGE ARUMBAKKAM CHENNAI
Chennai
TAMIL NADU
600 106
India 
Phone  8072768456  
Fax    
Email  amaravathy184@gmail.com  
 
Source of Monetary or Material Support  
DEPARTMENT OF PG POTHU MARUTHUVAM GOVERNMENT SIDDHA MEDICAL COLLEGE ARUMBAKKAM CHENNAI  
 
Primary Sponsor  
Name  AMARAVATHY S 
Address  GOVERNMENT SIDDHA MEDICAL COLLEGE ARUMBAKKAM CHENNAI 600106 TAMIL NADU 
Type of Sponsor  Other [Self] 
 
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 
AMARAVATHY S  ARIGNAR ANNA GOVERNMENT HOSPITAL OF INDIAN MEDICINE OF INDIAN MEDICINE  GOVERNMENT SIDDHA MEDICAL COLLEGE CHENNAI
Chennai
TAMIL NADU 
8072768456

amaravathy184@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: N908||Other specified noninflammatory disorders of vulva and perineum,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NAGA SANGU PARPAM  130mg BD oral dose with butter after food for a period of 48 days 
Comparator Agent  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Females of age between 18 to 45 yrs patients with whitish discharge Vulvovaginal itching erosions inflammation and erythematous surface is covered by whitish coat Positive candida albicans Diabetes mellitus 
 
ExclusionCriteria 
Details  Sexually Transmitted diseases (Gonorrhoea,Syphilis,HIV)
Non specific leucorrhoea
Pregnancy and lactation
Malignancy in uterus and Ovary
Vulvovaginosis caused by other organism 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Primary outcome is assessed by reduction in clinical symptoms like pruritis of vulva vulvovaginal inflammation and curdy white discharge.  One week 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary outcome is mainly assessed by comparing the safety parameters before and after the treatment  48 days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   15/11/2022 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Vulvovaginal infections are one of the most frequently diagnosed conditions in women. Nearly all vulvovaginal infections are caused by the yeast Candida species, with over 80% of all infections is due to Candida albicans. In worldwide, vaginal candidiasis is the second most common type of vaginal infection. In India, the complaint of vaginal discharges very common, more than 80% of vaginal infections are caused by candida albicans. 
The aim of the study is the management of “KABAYONIROGAM (VULVO-VAGINAL CANDIDISIS) with the Siddha Medicine NAGA SANGU PARPAM”
To study the safety profile and the efficacy of Siddha Medicine NAGA SANGU PARPAM in the treatment of KABAYONI ROGAM (Vulvovaginal candidiasis) . Primary outcome is assessed by reduction in clinical symptoms like pruritis of vulva, vulvovaginal inflammation and curdy white discharge. Outcome of the treatment is mainly assessed by Wet mount Examination and clinical prognosis. 
As the literary evidences support the usage of drugs in the disease, a hypothesis is created in such a way that the efficacy of the NAGA SANGU PARPAM will be a better solution for KABAYONI ROGAM
 
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