| CTRI Number |
CTRI/2024/12/077773 [Registered on: 06/12/2024] Trial Registered Prospectively |
| Last Modified On: |
04/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic
Preventive
Screening |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate the effect of Tila Tail Yonipichu with Amalaki Sita churna orally on Yonikandu in Pregnancy |
|
Scientific Title of Study
|
Single arm open label clinical study to evaluate the effect of Tila Tail Yonipichu with Amalaki Sita churna orally on Yonikandu in Pregnancy |
| 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.Chaitrali Somnath Tikhole |
| Designation |
MS Prasutitantra and Striroga |
| Affiliation |
MAM’s Sumatibhai Shah Ayurved Mahavidyalaya |
| Address |
MAM’s Sumatibhai Shah Ayurved Mahavidyalaya,Malwadi,Hadapsar, Pune.
OPD No.12,Department Of Prasutitantra And Striroga,Sane Guruji Arogya Kendra,Malwadi,Hadapsar,Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
7767033691 |
| Fax |
|
| Email |
chaitralitikhole17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Mandakini Sanjog Ghorpade |
| Designation |
Head Of Department Of Prasutitantra And Striroga |
| Affiliation |
MAM’s Sumatibhai Shah Ayurved Mahavidyalaya |
| Address |
MAM’s Sumatibhai Shah Ayurved Mahavidyalaya,Malwadi,Pune.
OPD No.12,Department Of Prasutitantra And Striroga, Sane Guruji Arogya Kendra, Malwadi,Hadapsar,Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
9822007570 |
| Fax |
|
| Email |
mandaghorpade@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Chaitrali Somnath Tikhole |
| Designation |
MS Scholar Prasutitantra And Striroga |
| Affiliation |
MAM’s Sumatibhai Shah Ayurved Mahavidyalaya |
| Address |
MAM’s Sumatibhai Shah Ayurved Mahavidyalaya,Malwadi,Hadapsar,PuneOPD No.12,Department Of Prasutitantra And Striroga,Sane Guruji Arogya Kendra,Malwadi,Hadapsar,Pune.
Pune
MAHARASHTRA
411028
India |
| Phone |
7767033691 |
| Fax |
|
| Email |
chaitralitikhole17@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Prasutitantra And Striroga,Sane Guruji Arogya Kendra,Malwadi,Hadapsar,Pune 411028 |
|
|
Primary Sponsor
|
| Name |
Sane Guruji Arogya Kendra |
| Address |
Sane Guruji Arogya Kendra, Malwadi,Hadapsar, 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 Chaitrali Somnath Tikhole |
Sane Guruji Arogya Kendra |
OPD No.12,Department Of Prasutitantra And Striroga,Sane Guruji Arogya Kendra,Malwadi, Hadapsar,Pune 411028
Pune
MAHARASHTRA |
7767033691
chaitralitikhole17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, MAMs Sumatibhai Shah Ayurved Mahavidyalaya and Sane Guruji Arogya Kendra |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O988||Other maternal infectious and parasitic diseases complicating pregnancy, childbirth and the puerperium. Ayurveda Condition: GARBINIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Yonipichu | (Procedure Reference: Charak Chikitsa 19/46, Procedure details: 1) Treatment form – Yonipichu Locally
2) Route – Yonipichu per vaginally
3) Duration – Yonipichu will be kept till 4-6 hours or till the urge to void urine (aamutrakale) once for 7 consecutive days. 4) Matra of Tila Tail for Yonipichu is 15 ml.
5) Sterile pichu soaked in Tila tail will be inserted with the index Finger into vagina in such a way that the thread of the pichu should come out of vagina.)
(1) Medicine Name: Amalaki - Sita churna , Reference: Charak Chikitsa 30/117, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant patient having signs and symptoms of Yonikandu will be taken irrespective of age parity and gestational age |
|
| ExclusionCriteria |
| Details |
Known case of Diabetes Mellitus
Patient with VDRL and HIV
Herpes genitalis
Syphilis |
|
|
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 evaluate the effect of Tila Tail Yonipichu and Amalaki Sita churna orally on Yonikandu in pregnancy |
Treatment will be given for 7
consecutive days
Tila Tail Yonipichu once a day for 7 consecutive days and Amalaki Sita churna orally two times a day for 7 consecutive days will be given to the patients
Follow up & Assessment will be done Pre-treatment and on every 7 days of treatment and after completion of treatment and final observation will be recorded on 7th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Literature Study Of Yonikandu In Pregnancy
To Observe Adverse Effects If Any |
Study Will Be Done Using Ayurvedic Granthas And Modern Texts
Preparation Of Drugs Will Be Done According To Standard Procedure
During Treatment Observation Will Be Done For Any Adverse Effect On Patients |
|
|
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)
|
16/12/2024 |
| 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 Single arm open label clinical study to evaluate effect of Tila Tail Yonipichu with Amalaki Sita churna orally on Yoni Kandu in Pregnancy Primary objective is to evaluate the effect of Tila Tail Yonipichu and Amalaki Sita churna orally for 7 consecutive days on Yonikandu in pregnancy Daily assessment of signs and symptoms will be done and observation will be drawn from the outcome of patients |