| CTRI Number |
CTRI/2021/04/032878 [Registered on: 16/04/2021] Trial Registered Prospectively |
| Last Modified On: |
15/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
TO STUDY THE EFFECT OF LODHRADI VARTI IN SHWETAPRADARA WITH SPECIAL REFERENCE TO VAGINAL CANDIDIASIS. |
|
Scientific Title of Study
|
“RANDOMIZED OPEN CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF LODHRADI VARTI IN SHWETAPRADARA WITH SPECIAL REFERENCE TO 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 |
Deepali Abaji Gaikwad |
| Designation |
PG scholar Prasuti Tantra and striroga 2 nd year |
| Affiliation |
Yashwant Ayurvedic college P G T & R C |
| Address |
Yashwant Ayurvedic College,Departmenta- prasuti tantra and Striroga , Kodoli Tal- panhala Dist- Kolhapur
Yashwant Ayurvedic College, Department- Prasuti tantra and Striroga , Kodoli , Tal- Panhala Dist- kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
7387913406 |
| Fax |
|
| Email |
deepaligaikwad411@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrKavita C Mule |
| Designation |
MS Prasutitantra and strirog |
| Affiliation |
Yashwant Ayurvedic college P G T & R C |
| Address |
Yashwant Ayurvedic College, Kodoli Tal- Panhala Dist- Kolhapur
Yashwant Ayurvedic College, Kodoli Tal- Panhala Dist- Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9423277612 |
| Fax |
|
| Email |
KVT126@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Deepali Abaji Gaikwad |
| Designation |
PG scholar Prasuti Tantra and striroga 2 nd year |
| Affiliation |
Yashwant Ayurvedic college P G T & R C |
| Address |
Yashwant Ayurvedic College,Department- Prasuti tantra and Striroga, Kodoli Tal - Panhala Dist- Kolhapur
Behind Sai park Neel dip niwas jadhavwadi Tal- phaltan Dist- Satara
Kolhapur
MAHARASHTRA
415523
India |
| Phone |
7387913406 |
| Fax |
|
| Email |
deepaligaikwad411@gmail.com |
|
|
Source of Monetary or Material Support
|
| GMP certified laboratories |
|
|
Primary Sponsor
|
| Name |
Deepali Abaji Gaikwad |
| Address |
Behind Sai park ‘Neel dip niwas ’ jadhavwadi Tal - phaltan Dist- Satara |
| 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 |
| Deepali Abaji Gaikwad |
OPD of Yashwant Ayurvedic College,PGT & RC, Kodoli |
Kodoli , Tal- Panhala, Dist- kolhapur pin-416114 Kolhapur MAHARASHTRA.
Dept-Prasutitantra evum Strirog.
Kolhapur
MAHARASHTRA |
7387913406
deepaligaikwad411@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| YASHWANT AYURVEDIC COLLEGE KODOLI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N00-N99||Diseases of the genitourinary system. Ayurveda Condition: Shwetapradarah, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lodhardi vatri in Shwetapradara with special reference to vaginal candidiasis |
Lodhardi varti in 50 patients once a day at night for seven days |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1 ) Patient between 20-40 years of age . 2) Patient diagnosed as shweta pradara 3) Patient irrespective of caste, income group, occupation. 4) Controlled DM (80-160 mg/ dl ) 5) Married only 6) Patient diagnosed with vaginal candidiasis. |
|
| ExclusionCriteria |
| Details |
1) Patient with major illness e.g.K/H/O-. HIV, HbsAg, 2) Patient having bacterial infection 3) K/H/O - CA cervix, cervical erosion 4)K/C/O- PID 5) Pregnancy 6) Uncontrolled DM( more than 160mg/dl 7) Oral contraceptive pills |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To treat and reduce the complaint of shwetapradara |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To treat and reduce the complaint of shwetapradara |
18 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
20/04/2021 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The prevalance rate of shwetapradara is increasing day by day. Vaginal candiasis antifungal treatment has side effects like abdominal pain ,freling seek, diarrhea etc so need to formulate the ayurvedic potential management with minimal side effect .Thus lodhardi varti in Shwetapradara overcomes the sympyoms and increase immunity and prevant recurrence of disease |