| CTRI Number |
CTRI/2019/07/020071 [Registered on: 08/07/2019] Trial Registered Prospectively |
| Last Modified On: |
19/01/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive
Screening |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Cervical cancer early detection and Prevention |
|
Scientific Title of Study
|
“Cervical Cancer screening and prevention by Ayurvedic intervention†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| No any |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gayathri Bhat N V |
| Designation |
Professor |
| Affiliation |
SDM College of Ayurveda & Hospital |
| Address |
OPD No 16
SDM College of Ayurveda and Hospital
Thanniruhalla
B M Road
Hassan 573201
Thanniruhalla
B M Road
Hassan 573201
Hassan
KARNATAKA
573201
India |
| Phone |
9844437917 |
| Fax |
|
| Email |
drgayathribhat@sdmcahhassan.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gayathri Bhat N V |
| Designation |
Professor |
| Affiliation |
SDM College of Ayurveda & Hospital |
| Address |
OPD NO 16
SDM College of Ayurveda and Hospital
Thanniruhalla
B M Road
Hassan 573201
Thanniruhalla
B M Road
Hassan 573201
Hassan
KARNATAKA
573201
India |
| Phone |
9844437917 |
| Fax |
|
| Email |
drgayathribhat@sdmcahhassan.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gayathri Bhat N V |
| Designation |
Professor |
| Affiliation |
SDM College of Ayurveda & Hospital |
| Address |
OPD no 16
SDM College of Ayurveda and Hospital
Thanniruhalla
B M Road
Hassan 573201
Thanniruhalla
B M Road
Hassan 573201
Hassan
KARNATAKA
573201
India |
| Phone |
9844437917 |
| Fax |
|
| Email |
drmadhu.ayu@gmail.com |
|
|
Source of Monetary or Material Support
|
| rajiv Gandhi Universuty Health Sciences
4th T block
Jayanagara, Bangalore 04 |
|
|
Primary Sponsor
|
| Name |
RGUHS University |
| Address |
4th block
Jayanagar
Bangalore |
| Type of Sponsor |
Other [Health university] |
|
|
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 Gayathri Bhat N V |
OPD number 16 |
SDM College of Ayurveda and Hospital
Hassan
Hassan
KARNATAKA |
9844437917
drgayathribhat@sdmcahhassan.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
women in active reproductive period |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Single group |
Yoni Prakshalana with Guduchyadi kwatha
Yoni Pichu with Guduchyadi Taila for 7days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1. Women screened by pap smear and having abnormal cervical cells with or without actual symptoms of cervical cancer.
2. Women with normal pap smear but evidence of clinical symptoms of affected cervix.
3. Irrespective of parity.
4. Irregular or inter menstrual bleeding
5. Post-menopausal bleeding
6. Post coital bleeding
7. Abnormal vaginal discharge with or without foul smell
8. Pelvic pain
|
|
| ExclusionCriteria |
| Details |
1. Abnormal pap smears which needs higher investigations.
2. Cancer in situ, advanced stages.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevention of cervical cancer with early detection by screening and ayurvedic intervention |
7days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in mortality and morbidity rate of the cervical cancer |
2years |
|
|
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 1 |
|
Date of First Enrollment (India)
|
01/01/2020 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Suspended |
| Recruitment Status of Trial (India) |
Suspended |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Cervical
cancer is life threatening disease in the women in reproductive and post
reproductive age. The incidence of cervical cancer and its mortality rate is
very high in India comparing to other nations. During previous screening camps
conducted, we witnessed more number of beneficiaries in this regard and many
women found to have high risk for cervical cancer. Owing to this problem in
particular area, this project is undertaken. Screening will be done for 500
women with well-prepared questionnaire, clinical symptoms and by pap smear
test. The 100 women who come under high risk of cervical carcinoma will be
taken for the preventive care by Ayurvedic intervention. Sthanika chikitsa by Yoni
prakshalana with freshly prepared Guduchyadi kashaya and Yoni Pichu with
Guduchyadi taila will be done for 7days. The pap smear will be repeated on
follow up at the end of one month. The recorded data will be analyzed
statistically, presented in international conferences and publish in
international peer reviewed journals. Thus helping the women community worldwide. |