| CTRI Number |
CTRI/2019/05/018948 [Registered on: 06/05/2019] Trial Registered Prospectively |
| Last Modified On: |
03/05/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To assess the effect of panchavalkala kashaya vaginal douche and its internal administration in bacterial vaginosis |
|
Scientific Title of Study
|
Pre and post clinical study to assess the effect of panchavalkala kashaya yoniprakshalana and its internal administration in bacterial vaginosis (paithiki yonivyapath) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manju parvathy S |
| Designation |
Second year PG scholar |
| Affiliation |
Amrita school of Ayurveda |
| Address |
Kottor Kausthubham
Ellampallill Payyanallur P O
Pin :690504
Amrita school of Ayurveda
amrita vishwa vidyapeetam
amritapuri
Kollam
KERALA
690504
India |
| Phone |
9497615452 |
| Fax |
|
| Email |
manjumeledathu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hemavathi S K |
| Designation |
Professor and HOD |
| Affiliation |
Amrita school of ayurveda Amrita vishwa vidhyapeetam |
| Address |
Amrita school of ayurveda
Amrita vishwa vidyapeetam
Amritapuri
Amrita school of Ayurveda
amrita vishwa vidyapeetam
amritapuri
Kollam
KERALA
690526
India |
| Phone |
9446962291 |
| Fax |
|
| Email |
drhemavathi.sk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Manju parvathy S |
| Designation |
Second year PG scholar |
| Affiliation |
Amrita school of Ayurveda |
| Address |
Kottor Kausthubham
Ellampallill Payyanallur P O
Pin :690504
Amrita school of Ayurveda
amrita vishwa vidyapeetam
amritapuri
KERALA
690504
India |
| Phone |
9497615452 |
| Fax |
|
| Email |
manjumeledathu@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
manju parvathy s |
| Address |
amritha school of ayurveda
amrita vishwa vidyapeetam
amritapuri |
| 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 |
| manju parvathy s |
amrita school of ayurveda |
Department of stree roga and prasuti tantra
First floor
amrita school of ayurveda
amrita vishwa vidyapeetam
amritapuri
Kollam
KERALA |
9497615452
manjumeledathu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee IEC-AIMS-2018-AYUR-253 |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Pre and post clinical study to assess the effect of panchavalkala kashaya yoniprakshalana and its internal administration in bacterial vaginosis (paithiki yonivyapath)
|
panchavalkala kashaya yoni prakshalana and its internal administration in bacterial vaginosis for 7 days.follow up for 1 month with internal administration. |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1.Sexually active women
2.18-60 yrs
3.Satisfing Amsels criteria
|
|
| ExclusionCriteria |
| Details |
1.PID
2.Known cases of Systemic diseases
3.Post delivery cases with in 45 days
4.Women in stage of pregnancy
5. known case of other vaginal infections.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
With Pre and post wet mount
Clue cells on microscopy-absent
Vaginal odour-absence of fishy odour in whiff test
Vaginal ph-less than 4.5 with ph paper.
|
37 days per patient |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| reccurence of bacterial vaginosis by using wet mount |
1 month follow up |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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 3 |
|
Date of First Enrollment (India)
|
15/05/2019 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
pre and post clinical trial to assess the effect of panchavalkala kashaya yoni prakshalana and its iternal administration in paithiki yoni vyapath by analaysing Amsels criteria |