| CTRI Number |
CTRI/2024/07/070148 [Registered on: 08/07/2024] Trial Registered Prospectively |
| Last Modified On: |
06/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To study the efficacy of Ksheerbala taila yoni pichu (Vaginal tampon) given in 9th Month of pregnancy to achieve Sukhaprasava (normal vaginal delivery) |
|
Scientific Title of Study
|
An open labelled randomised controlled clinicalstudy to evaluate the efficacy of Ksheerbala taila yoni Pichu(vaginal tampon) given in 9th month of pregnancy to Achieve sukhaprasava (normal Vaginal delivery) |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Smirti Mishra |
| Designation |
M.S Scholar Prasuti Tantra Avum Striroga |
| Affiliation |
Dr. D.Y. Patil College Of Ayurved And Research Centre,Pimpri,Pune |
| Address |
Opd No-2 Dr. D.Y. Patil College of Ayurved And Research Centre ,Pimpri Pune ,Maharashtra
Pin Code 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
7617651418 |
| Fax |
|
| Email |
tanumishra43837@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Pradnya shirke |
| Designation |
M.S Prasuti Tantra Avum Striroga |
| Affiliation |
Dr. DY Patil College Of Ayurved And Research Center ,Pimpri, Pune |
| Address |
Opd No-2 Dr. D.Y. Patil College Of Ayurved And Research Centre, Pimpri Pune, Maharashtra
Pin code 411018
Opd no-2 Dr. D.Y. Patil College Of Ayurved And Research Centre,Pimpri Pune ,Maharashtra
Pin code 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9623446110 |
| Fax |
|
| Email |
pradnyashirke2@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Smirti Mishra |
| Designation |
M.S Scholar Prasuti Tantra Avum Striroga |
| Affiliation |
Dr. D.Y. Patil College Of Ayurved And Research Centre, Pimpri ,Pune ,Maharastra |
| Address |
Opd No-2 Dr. D.Y. Patil College Of Ayurved And Research Centre ,Pimpri Pune,Maharashtra
Pin code 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
7617651418 |
| Fax |
|
| Email |
tanumishra43837@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.D.Y.Patil College of Ayurved and Research Centre Pimpri pune 411018 |
|
|
Primary Sponsor
|
| Name |
DrSmirti Mishra |
| Address |
Dr.D.Y.Patil College of Ayurved and Research Centre Pimpri pune ,Maharastra 411018 |
| 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 |
| Dr Smirti mishra |
Dr. D.Y. Patil College Of Ayurved And Research Centre, Pimpri,Pune |
Opd And Ipd Of Prasuti Tantra Avum Stri Roga Department ,Dr. D.Y. Patil College Of Ayurved And Research Centre ,Pimpri , Pune-411018
Pune
MAHARASHTRA |
7617651418
tanumishra43837@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR.D.Y. PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE, INSTITUTIONAL ETHICS COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O94||Sequelae of complication of pregnancy, childbirth, and the puerperium. Ayurveda Condition: GARBINIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:, Pathya/Apathya:yes, Pathya:Hematinic diet
Protein rich diet
Calcium and iron supplements , Apathya:Avoid spicy food
Travelling
Heavy work | | 2 | Intervention Arm | Procedure | - | yoni picu, योनि पिचॠ| (Procedure Reference: Charaka Samhita, Procedure details: 5ml Ksheerbala Taila yoni pichu( vaginal tampon) inserted twice in a week till expected delivery date under all aseptic precautions .)
|
|
|
|
Inclusion Criteria
|
| Age From |
22.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
All primigravida with age group between 22yrs to 35yrs with gestation age 36 completed weeks with cephalic presentation with adequate liquor |
|
| ExclusionCriteria |
| Details |
Multipara
Garbhopdravas like pregnancy induced hypertension (PIH) anemia cardiac disease
Patient having garbhavyapadas like intrauterine growth retardation oligohydromnios ,placenta previa |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of ksheerbala taila yoni pichu (vaginal tampon) in 9thmonth of pregnancy to achieve sukhaprasava (normal vaginal delivery) |
Twice in a week till edd by lmp(approx 4 weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe the adverse effect of ksheerbala taila yoni pichu |
Twice in a week till EDD by lmp(approx 4 weeks) |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
17/07/2024 |
| 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="6"
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 open labelled randomised controlled clinical study. The aim of this study to evaluate the efficacy of Ksheerbala Taila Yoni Pichu (vaginal tampon) to achieve sukhprasava.Total 42 participants will be enrolled in 2 groups (21 in each group)group A will be treated with Ksheerbala Taila Yoni and group B will be observed without yoni pichu of Ksheerbala Taila with required standard of care.the age group for study is 22yrs to 35 yrs pregnant female with GA 36 completed weeks.The final conclusion will be drawn on the basis of statistical methods. |