| CTRI Number |
CTRI/2020/03/024003 [Registered on: 16/03/2020] Trial Registered Prospectively |
| Last Modified On: |
04/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the effect of panchkola vati in post delivery(post natal care) |
|
Scientific Title of Study
|
A clinical study to evaluate the efficacy of panchkola vati in sutika awastha. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Namrata Maharu Rathod |
| Designation |
MS scholar streerog prasutitantra |
| Affiliation |
Dr D y patil college of Ayurved and research centre pimpri |
| Address |
Opd no 2
Dr D y patil college of ayurveda and research center pimpri pune
Sant tukaram nagar, pimpri colony, Pimpri Chinchwad 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
8830893029 |
| Fax |
|
| Email |
drnamratarathod1995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayashree Patil |
| Designation |
HOD streerog and prasutitantra |
| Affiliation |
Dr d y patil college of Ayurved and research centre pimpri |
| Address |
Dr.d y patil college of ayurveda and research center pimpri pune
Sant tukaram nagar, pimpri colony, Pimpri Chinchwad 411018
Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9921244690 |
| Fax |
|
| Email |
jayupa.patil6@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Namrata Maharu Rathod |
| Designation |
MS scholar streerog and prasutitantra |
| Affiliation |
Dr d y patil college of ayurved and research centre pimpri |
| Address |
Opd no 2
Dr D y patil college of ayurveda and research center pimpri pune
Sant tukaram nagar, pimpri colony, Pimpri Chinchwad 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
8830893029 |
| Fax |
|
| Email |
drnamratarathod1995@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr D Y PAtil college of Ayurved and research centre pimpri |
|
|
Primary Sponsor
|
| Name |
Dr Namrata Maharu Rathod |
| Address |
Dr Dy Patil college of Ayurveda and research centre sant tukaram
nagar 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 |
| Dr Namrata Maharu Rathod |
Dr d y patil college of ayurveda and research centre pimpri pune |
Streerog and prasutitantra opd no 2 and ipd
Dr d y Patil college
of ayurveda and
research centre,Sant tukaram nagar, pimpri colony, Pimpri Chinchwad 411018
Pune
Pune
MAHARASHTRA |
8830893029
drnamratarathod1995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and Recognition committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
50 post delivery women will be taken for trial.they should not have any chronic systemic disorder |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Panchkola vati (pimpli pimplimul nagar chavya chitrak ) |
50 post delivery women will be taken and treated with panchkola vati from expulsion of placenta till 45th day of puerperium and dose will be 2 tablets of 250mg twice a day with warm water.Duration of study will be 45 days and 10 follow ups will be given (0-7 the day,15th day,30thday,45th day) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Primi and multigravida
Women with vaginal and caesarean delivery
Women with episiotomy wound |
|
| ExclusionCriteria |
| Details |
Women with postpartum hemorrhage placental tension extensive perineal tear
Women having any fibroids
Women having any chronic systemic disorder |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To improve physiological condition after delivery
To provide more effective cheap safe and side effects free management to post delivery women |
The cure shall be assessed in 10follow ups from expulsion of placenta till 45th day of puerperium |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To improve physiological condition after delivery
To give her a safe cheap side effects free ayurvedic management |
45 days |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
20/03/2020 |
| Date of Study Completion (India) |
31/01/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aim of the study is to give ayurvedic treatment to post delivery women which not only improve her physiological condition but also protect her from the upcoming disease along with this we can give her safe cheap side effect free management in form of panchkola vati The trial will be conducted on 50post delivery women’s with Panchkola vati from expulsion of placenta to 45th day of puerperium and dose will be 2 tablets of 250mg twice a day with warm water And conclusion will be drawn from the collected data. |