| CTRI Number |
CTRI/2019/02/017861 [Registered on: 28/02/2019] Trial Registered Prospectively |
| Last Modified On: |
27/02/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
effect of single herbal drug on white dischagre |
|
Scientific Title of Study
|
Efficacy of Kundur (Boswalliaserrata)in Vulvovaginal Candidiasis;A Randamized Standard Controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nikhat kausar M Inamdar |
| Designation |
PG scholar,department of ilmul qabalat wa amraze niswa |
| Affiliation |
Luqman Unani Medical College, Hospital and Research Centre |
| Address |
Luqman Unani Medical College, Hospital and Research Centre,
department of Amraz-e-Niswa-o-qabalat, 12 Naubag, Vijaypur, Karnataka 586101
india
Luqman Unani Medical College, Hospital and Research Centre,
department of Amraz-e-niswa-o-qabalat, 12 Naubag, Vijaypur, Karnataka 586101
Bijapur
KARNATAKA
586101
India |
| Phone |
7795447144 |
| Fax |
|
| Email |
nikhatinamdar72@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mariyam roqaiya |
| Designation |
Assistant profesor |
| Affiliation |
Luqman Unani Medical College |
| Address |
Luqman Unani Medical College, Hospital and Research Centre, ,department of Amraz-e-niswa-o-qabalat,12 naubag Vijaypur, Karnataka 586101
india
Luqman Unani Medical College, Hospital and Research Centre,department Amraz-e-niswa-o-qabala, 12 Naubag, Vijaypur, Karnataka 586101
india
Bijapur
KARNATAKA
586101
India |
| Phone |
9632560839 |
| Fax |
|
| Email |
dr.mroqaiya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mariyam roqaiya |
| Designation |
Assistant profesor |
| Affiliation |
Luqman Unani Medical College |
| Address |
Luqman Unani Medical College, Hospital and Research Centre, department of Amraz-e-niswa-o-qabalat ,12 naubag Vijaypur, Karnataka 586101
india
Luqman Unani Medical College, Hospital and Research Centre,department pf Amraz-e-niswa-o-qabalat 12 Naubag, Vijaypur, Karnataka 586101
india
Bijapur
KARNATAKA
586101
India |
| Phone |
9632560839 |
| Fax |
|
| Email |
dr.mroqaiya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Luqman Unani Medical College, Hospital and Research Centre ,Department of Amraz-e-niswa-o-qabalat,12 Naubag bijapur |
|
|
Primary Sponsor
|
| Name |
Nikhat kausar M Inamdar |
| Address |
Luqman Unani Medical College, Hospital and Research Centre, 12 Naubag, Vijaypur, Karnataka 586101 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Nikhat Kausar Inamdar |
Luqman Unani Medical College Hospital and Research Centre |
Luqman Unani Medical College Hospital and Research center ,Department of Amraz-e- niswa-o-qabalat,12 Naubag
Bijapur
KARNATAKA |
7795447144
nikhatinamdar72@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| LUMC Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N760||Acute vaginitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kundur (Gum resins of Boswellia serrata) |
Kundur will be powdered and tablet (1gm) will be made and 1 tablet per vaginally will be given at bed time daily for 21 days. |
| Comparator Agent |
Miconazole |
100 mg vaginal suppository, one suppository per vaginally will be given at bed time daily for 7 day |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.Married women between 18 to 45 yearsof ages.
2.Clinically diagnosed cases of vulvovaginal candidiasis.
|
|
| ExclusionCriteria |
| Details |
1.Pregnant ,lactating and unmarried women.
2.Suspected of having concurrent vaginal infections.
3.Patients having antifungal, antibiotic or corticosteroid therapies within past 2 weeks.
4.Patients with diabetes mellitus.
5.Patients on oral contraceptive pills.
6.Patients having sexually transmitted diseases.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.Improvement in subjective parameters |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.Improvement in objective parameters |
21days |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/03/2019 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
this is a randamized standard control trial to see the efficacy of kundur in vulvovaginal candidasis ,kundur wil be powdered and 1gm tablet will be given per vaginaly for 21 days.this wil be conducted in luqman unani medical college,hospital and research center bijapur in india |