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
|
|
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
|
|
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 PARPAMâ€
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 |