| CTRI Number |
CTRI/2019/06/019655 [Registered on: 12/06/2019] Trial Registered Retrospectively |
| Last Modified On: |
11/06/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to assess the combined effect of Aragvadha twak kashaya yoni prakshalana and Aragvadha twak kashaya internal administration in Vaginal candidiasis |
|
Scientific Title of Study
|
A single arm pre and post study to assess the combined effect of Aragvadha twak kashaya yoni prakshalana and Aragvadha twak kashaya internal administration in Vaginal candidiasis (slaismiki yonivyapat) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr VandanaKVasudevan |
| Designation |
PG Scholar |
| Affiliation |
Amrita School of Ayurveda |
| Address |
Department of Prasuti Tantra and Stri Roga
Amrita School of Ayurveda
Kollam
Kerala
Department of Prasuti Tantra and Stri Roga
Amrita School of Ayurveda
Kollam
Kerala
Kollam
KERALA
690546
India |
| Phone |
9746839985 |
| Fax |
|
| Email |
vandanakdevan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr HemavathiSK |
| Designation |
Head of Department and Professor |
| Affiliation |
Head of Department and Professor |
| Address |
Department of Prasuti Tantra and Stri Roga
Amrita School of Ayurveda
Kollam
Kerala
Department of Prasuti Tantra and Stri Roga
Amrita School of Ayurveda
Kollam
Kerala
Kollam
KERALA
690546
India |
| Phone |
9746839985 |
| Fax |
|
| Email |
drhemavathi.sk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr VandanaKVasudevan |
| Designation |
PG Scholar |
| Affiliation |
Amrita School of Ayurveda |
| Address |
Department of Prasuti Tantra and Stri Roga
Amrita School of Ayurveda
Kollam
Kerala
Department of Prasuti Tantra and Stri Roga
Amrita School of Ayurveda
Kollam
Kerala
Kollam
KERALA
690546
India |
| Phone |
9746839985 |
| Fax |
|
| Email |
vandanakdevan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita Ayurveda Hospital
Vallikkavu,
Kollam
Kerala.
PIN:690546 |
|
|
Primary Sponsor
|
| Name |
DrVandanaKVasudevan |
| Address |
Amrita School of Ayurveda
Kollam
Kerala |
| Type of Sponsor |
Other [] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DrHemavathiSK |
Head of Department
Department of Prasuti Tantra and Stri Roga
Amrita School of Ayurveda
Kollam
Kerala |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrVandanaKVasudevan |
Amrita Ayurveda Hospital |
Room No: 118,
Out Patient Divisison,
Dept. of Prasuti tantra and stree roga.
Kollam
KERALA |
9746839985
vandanakdevan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee,Amrita Institute of Medical Science and Research Centre,Kochi,Kerala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B373||Candidiasis of vulva and vagina, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aragwadha twak choornam |
1.Yoni prakshalanam
a.Dose-2 litres
b.Frequency-Once daily for 10 days
c.Route of administration-Per vaginum
2.Internal Administration
a.Dose-48 ml
b.Frequency-twice daily for 40 days
c.Route of Administration- Orally |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Diagnosed with Candidiasis |
|
| ExclusionCriteria |
| Details |
Pregnancy
Known case of Diabetes mellitus
Known case of Sexually Transmitted Disease/Pelvic Inflammatory Disease
Known case of Malignancies
Under Oral Contraceptive Pills
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Discharge scale more than mild
5-d Itch Scale more than mild |
AT 10th and 40th days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Candidial Spore count |
at 10th and 40th days |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
07/01/2018 |
| Date of Study Completion (India) |
15/12/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a single arm, opren label, pre and post trial on the efficacy of Aragvadha twak kashaya yoni prakshalana and aragvadha twak kashaya internal administration for 40 days in 20 patients with vaginal candidiasis that will be conducted in a single center in India. The primary outcome measures will be discharge scale and 5-D Itch scale at 10th and 40th days. The secondary outcomes will be candidial spore count at 10th and 40th days. |