| CTRI Number |
CTRI/2025/05/086934 [Registered on: 14/05/2025] Trial Registered Prospectively |
| Last Modified On: |
14/05/2025 |
| 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 effect of Pippalyadi Lepa on abdomen to increase Contractions during labour. |
|
Scientific Title of Study
|
Randomized Controlled Trial on Efficacy of Pippalyadi Nabhigat Lepa to Achieve the Progress of Uterine Contractions During 1st Stage of Labour(Sukhaprasav) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pratiksha Limbhore |
| Designation |
M.S Scholar Prasuti Tantra Avum Striroga |
| Affiliation |
Dr.D.Y.Patil College of Ayurveda and Research Centre,Pimpri,Pune,Maharashtra |
| Address |
OPD No-2,Dr.D.Y.Patil College of Ayurveda and Research Centre,Pimpri,Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9527461793 |
| Fax |
|
| Email |
pratiksha4546@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrJayashree Patil |
| Designation |
M.D. Prasuti Tantra Avum Striroga |
| Affiliation |
Dr.D.Y.Patil College of Ayurveda and Research Centre,Pimpri,Pune |
| Address |
OPD No-2,Dr.D.Y.Patil College of Ayurveda and Research Centre,Pimpri,Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9921244690 |
| Fax |
|
| Email |
jayupa.patil6@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pratiksha Limbhore |
| Designation |
M.S Scholar Prasuti Tantra Avum Striroga |
| Affiliation |
Dr.D.Y.Patil College of Ayurveda and Research Centre,Pimpri,Pune |
| Address |
OPD No-2,Dr.D.Y.Patil College of Ayurveda and Research Centre,Pimpri,Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9527461793 |
| Fax |
|
| Email |
pratiksha4546@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.D.Y.Patil College of Ayurveda and Research Centre,Pimpri,Pune,Maharashtra 411018 |
|
|
Primary Sponsor
|
| Name |
Pratiksha Limbhore |
| Address |
Dr.D.Y.Patil College of Ayurveda and Research Centre,Pimpri,Pune 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 |
| DrPratiksha Limbhore |
Dr.D.Y.Patil College of Ayurveda and Research Centre,Pimpri,Pune |
IPD of Prasuti Tantra Avum Stri Roga Department, 1st floor of,Dr.D.Y.Patil College of Ayurveda and Research Centre,Pimpri,Pune-411018
Pune
MAHARASHTRA |
9527461793
pratiksha4546@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr.D.Y.Patil College of Ayurveda and Research Centre,Pimpri,Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O80||Encounter for full-term uncomplicated delivery. Ayurveda Condition: GARBAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Placebo group | Patients enrolled in controlled group will be observed without applying Pipplyadi Nabhigata Lepa. | | 2 | Comparator Arm | Procedure | - | Alepa-karma, आलेप-कर्म | (Procedure Reference: Dravyaguna vigyan yadavji , Procedure details: The selected freshly dried drugs are taken in a clean khalva yantra.each drug taken in equal amount(7gm)and pounded to fine powder form and filtered.This filtered powder will be packed in 14gm amount of sachet.The lepa will be formed by adding warm water and 5ml errand tails.The lepa will be applied on nabhipradesh
1.opposite direction of hair follicles 2.Approximately 0.5cm in thickness 3.within 10-12cm radius from umbilicus(nabhi).The lepa will be removed within 15-18 minutes when it will get dry and removed with the help of water soaked sponge.)
|
|
|
|
Inclusion Criteria
|
| Age From |
22.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
All Primigravida and Multigravida with age group between 22yrs to 35yrs with Gestational age 36 completed weeks who are in Labour with Cephalic presentation with Adequate liquor |
|
| ExclusionCriteria |
| Details |
Patient who K/C/O Garbhopdrava like PIH ,Anaemia,Cardiac disease
Patients who are K//C/O Garbhavyapad like Intrauterine Growth Retardation,Oligohydramnios,Placenta previa |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement and progression of uterine contractions using Partograph before and after the Lepa treatment |
Three times from onset of labour(3-4 hours)-with 1 hour of interval |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe the adverse effect of Pippalyadi Nabhigat Lepa |
Three times from onset of labour(3-4 hours)-with 1 hour of interval |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
01/06/2025 |
| 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 Yet Recruiting |
| 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 randomized controlled clinical study ,the aim of the study is to evaluate the efficacy of Pippalyadi Nabhigat Lepa to achieve the progress of uterine contractions(Sukhaprasav) during first stage of labour.Total 36 participants will be enrolled in two groups(18 in each group).Group A will be treated with Pippalyadi Nabhigat Lepa and Group B will be observed without Pippalyadi Nabhigat Lepa with required standard of care.The age group for study is 22-35yrs pregnant females with gestational age 36 completed weeks who are in labour.The final conclusion will be drawn on the basis of statistical methods. |