| CTRI Number |
CTRI/2018/04/013044 [Registered on: 04/04/2018] Trial Registered Prospectively |
| Last Modified On: |
24/03/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of herbal drug on itching in female external genitalia |
|
Scientific Title of Study
|
Effect of Palasha Pushpa churna and Palasha seed taila pichu in bacterial vulvovaginitis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neha singh |
| Designation |
Junior resident |
| Affiliation |
Banaras Hindu University |
| Address |
Department of prasuti tantra,Dhanwantri bhawan, Faculty of Ayurveda, Institute of medical sciences, Banaras Hindu university,varanasi.
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7599293877 |
| Fax |
|
| Email |
ns198789@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Professor Neelam |
| Designation |
Professor and Head of Department |
| Affiliation |
Banaras Hindu University |
| Address |
Department of prasuti tantra,Dhanwantri bhawan, Faculty of Ayurveda, Institute of medical sciences, Banaras Hindu university,varanasi.
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
|
| Fax |
|
| Email |
drneelamaditi@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Professor Neelam |
| Designation |
Professor and Head of Department |
| Affiliation |
Banaras Hindu University |
| Address |
Department of prasuti tantra,Dhanwantri bhawan, Faculty of Ayurveda, Institute of medical sciences, Banaras Hindu university,varanasi.
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
|
| Fax |
|
| Email |
drneelamaditi@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Sirsunderlal Hospital,Institute of medical sciences,Banaras Hindu University,Varanasi. |
|
|
Primary Sponsor
|
| Name |
Banaras Hindu University |
| Address |
Sir sunderlal Hospital,Institute of Medical sciences,Banaras Hindu University,varanasi |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Neha singh |
Department of prasuti tantra,Dhanwantri bhawan,Faculty of Ayurveda, Institute of Medical sciences, Banaras Hindu University,Varanasi. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Neha Singh |
Banaras Hindu University |
Department of prasuti tantra,Dhanwantri bhawan,Faculty of Ayurveda,Institute of medical sciences,Banaras Hindu University,varanasi.
Varanasi
UTTAR PRADESH |
7599293877
ns198789@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee,Banaras Hindu University. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
patients having sign and symptoms of bacterial vulvovaginitis., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ayurvedic formulation Palasha pushpa churna and Palasha seed taila pichu. |
Palasha pushpa churna 3gm twice daily along with Palasha seed taila pichu applied locally(vaginally) in night for 21 days to 20 patients. |
| Intervention |
Ayurvedic formulation palasha pushpa churna. |
Palasha pushpa churna 3gm twice daily to 20 patients with luke warm water for 21 days. |
| Intervention |
Ayurvedic formulation Palasha seed taila pichu. |
Palasha seed taila pichu applied locally (vaginally)in night for 21 days to 20 patients. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Married women having sign and symptoms of vulvovaginitis like vaginal discharge (purulent or blood stained), pruritis or soreness in external genitalia, painful urination, vaginal bleeding, pain in vulva and vagina. |
|
| ExclusionCriteria |
| Details |
1.Unmarried patients.
2.Pregnant and lactating mothers.
3.Patients associated with any currently ongoing research study.
4.Psychiatric patients .
5.Patients having any allergy to the drugs.
6.Patients with any specific disease specially of chronic nature such as marked anaemia , T.B., HIV, hypertension, diabetes, hypo/hyper thyroidism, cardiac disese, renal disease, jaundice or any other disorders influencing general physical health .
7.Patient having any organic pathology such as endometriosis, fibroid uterus, carcinoma of uterus and cervix.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Analysis of improvement in sign and symptoms of bacterial vulvovaginitis through various parameters. |
first follow up at 7th day,second follow up at 14th day and last follow up at 21th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
05/04/2018 |
| 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="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is an open label, randomised,single center trial evaluating the effect of Ayurvedic formulation Palasha pushpa churna 3gm two times per day with Luke warm water and palasha seed m taila pichu applied locally in management of bacterial vulvovaginitis. Married women of age group 20 to 40 years having sign and symptoms of vaginal discharges,itching in external genitalia, painful urination, vaginal bleeding, pain in vulva and vagina will be selected for study for relieving sign and symptoms. |