| CTRI Number |
CTRI/2024/11/077507 [Registered on: 29/11/2024] Trial Registered Prospectively |
| Last Modified On: |
29/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Screening
Other (Specify) [Therapeutic] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate the effect of Durvadi Taila Yoni Pichu on Garbhashay Griva Gata vrana with special reference to Cervical Erosion
|
|
Scientific Title of Study
|
An Open Label Single Arm Clinical Study of Durvadi Taila Yoni Pichu on Garbhashay Griva Gata vrana with special reference to Cervical Erosion.
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pooja Dipak Sawai |
| Designation |
MS Scholar Stri Roga and Prasuti Tantra |
| Affiliation |
Sumatibhai Shah Ayurved Mahavidyalaya |
| Address |
Sumatibhai Shah Ayurved Mahavidyalaya Malwadi
Hadapsar Pune Opd no 12 Department of Prasuti
Tantra and Striroga Sane Guruji Arogya Kendra
Malwadi Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
9689579974 |
| Fax |
|
| Email |
Sawaipooja27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Trupti Kalyan Gawade |
| Designation |
Reader Department Of Prasuti Tantra And Strirog |
| Affiliation |
Sumatibhai Shah Ayurved Mahavidyalaya |
| Address |
Sumatibhai Shah Ayurved Mahavidyalaya Malwadi
Hadapsar Pune Opd no 12 Department of Prasuti Tantra and Striroga Sane Guruji Arogya Kendra Malwadi Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
9881840224 |
| Fax |
|
| Email |
truptigawade13@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pooja Dipak Sawai |
| Designation |
MS Scholar Stri Roga And Prasuti Tantra |
| Affiliation |
Sumatibhai Shah Ayurved Mahavidyalaya |
| Address |
Sumatibhai Shah Ayurved Mahavidyalaya Malwadi
Hadapsar Pune Opd NO 12 Department OF Prasuti
Tantra And Striroga Sane Guruji Arogya Kendra
Malwadi Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
09689579974 |
| Fax |
|
| Email |
Sawaipooja27@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Prasuti Tantra And Striroga Sane Guruji Arogya Kendra
Malwadi Hadapsar Pune 411028 |
|
|
Primary Sponsor
|
| Name |
Sane Guruji Arogya Kendra |
| Address |
Sane Guruji Arogya Kendra Malwadi Hadpasar Pune 411028 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Pooja Dipak Sawai |
Sane Guruji Arogya Kendra |
OPD no. 12 Department of Prasuti tantra and strirog Sane Guruji Arogya Kendra Malwadi Hadpasar Pune 411028
Pune
MAHARASHTRA |
09689579974
Sawaipooja27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N72||Inflammatory disease of cervix uteri. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Durvadi Tail Yoni Pichu | (Procedure Reference: Charak Chikitsasthana 25/93, Procedure details: )An autoclaved pichu will be kept in vagina on area focusing on eroded portion
with Help of sim’s speculum by taking all the aseptic precaution.
g)Pichu will be kept for 4 hour or till the urge to void urine .
h)duration of trails: 7days in each cycle for two consecutive cycles . )
|
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
a) All patients with complaints like white discharge per vaginum, inter menstrual
bleeding, post coital bleeding, dyspareunia having cervical erosion on per
speculum examination.
b) Age between 19-50years.
c) Married women irrespective of parity.
d) Patient having chronic and recurrent vaginitis. |
|
| ExclusionCriteria |
| Details |
a)Pregnancy
b)Woman less than or equal to 6 weeks after delivery.
c)Patients on oral contraceptive pills.
d)Known case of CIN or treated case of CIN or cervical cancer (malignant changes on pap
smear)
e)Women with frank growth of cervix.
f)Positive patients of HIV, HBSAG, VDRL
g)Patients with IUCD insertion.
h)Patients having severe systemic disorders like Diabetes, Hypertension, Tuberculosis,etc. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the effect of Durvadi tail in Garbhashay Griva Gata vran with special
reference to cervical erosion |
Pichu Kept for consecutive 7days after menstruation for 2consecutive cycle
Follow up and assessment will be done pretreatment and on 7th days of treatment And after completions of treatment
Observation will be done on 7th day of treatment 2nd cycle |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the literature regarding Garbhashaya grivagata vrana & cervical
erosion from Ayurvedic & modern literature in detail & understand the concept.
To look for adverse effects, if any. |
Study will be done using Ayurvedic Granthas
and modern texts.
Preparation of drugs will be done according to
the standard procedure.
During the regimen observation will be done for
any adverse effects. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
10/12/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is an Open Label Single Arm Clinical Study of ’Durvadi Taila Yoni Pichu on Garbhashay Griva Gata Vrana’ with special reference to Cervical Erosion. Primary objective is to study the effect of Durvadi tail in Garbhashay Griva Gata vran with specialreference to cervical erosion . Observation will be drawn from the outcome of patients. |