| CTRI Number |
CTRI/2020/01/022832 [Registered on: 16/01/2020] Trial Registered Prospectively |
| Last Modified On: |
15/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To Study The Effect Of Prajata Care Kit in sutika (Postnatal period) |
|
Scientific Title of Study
|
A Clinical Study To Evaluate The Efficacy Of Prajata Care Kit In The Management of Sutika Paricharya With Special Reference To Postnatal Care |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vedshruti Dongre |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute Of Ayurved |
| Address |
Room no 308 Department Of Prasuti Tantra Evum Stree Roga Parul Institute Of Ayurved Parul University P O Limda Tal Waghodia
Same As Above
Vadodara
GUJARAT
391760
India |
| Phone |
9399482036 |
| Fax |
02668-260201 |
| Email |
vedshrutidongre101@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rita B Makim |
| Designation |
Professor |
| Affiliation |
Parul Institute Of Ayurved |
| Address |
Room no 308 Department Of Prasuti Tantra Evum Stree Roga Parul Institute Of Ayurved Parul University P O Limda Tal Waghodia
Same as Above
Vadodara
GUJARAT
391760
India |
| Phone |
7990727524 |
| Fax |
02668-260201 |
| Email |
ritamakim@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rita B Makim |
| Designation |
Professor |
| Affiliation |
Parul Institute Of Ayurved |
| Address |
Room no 308 Department Of Prasuti Tantra Evum Stree Roga Parul Institute Of Ayurved Parul University P O Limda Tal Waghodia
Same as Above
Vadodara
GUJARAT
391760
India |
| Phone |
7990727524 |
| Fax |
02668-260201 |
| Email |
ritamakim@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul Ayurved Hospital,Parul University,Vadodara,391760 |
|
|
Primary Sponsor
|
| Name |
Parul Institute Of Ayurved |
| Address |
Room No 308 Department Of Prasuti Tantra Evum Stree Roga Parul Institute Of Ayurved Parul University PO Limda Tal Waghodia Vadodara |
| 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 Rita Makim |
Parul Ayurved Hospital |
Room no 308 Department of Prasuti tantra evum Stree roga Parul Institute of Ayurved Parul University Waghodia
Vadodara
GUJARAT |
7990727524
02668-260201
ritamakim@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee For Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Prajata Care Kit (According to Acharya Harit) |
Day 1 of delivery Kwath of Lodhra Arjun Kadamb Devdaru Beejkahva and Bair 40 ml BD orally after food for 2 days Sarvang abhyanga with Til taila external application followed by swedan with Ushna jala once a day for 10 days Day 2 of delivery Maudaka of Shunthi Haritaki and Gud 10 gm BD Before food orally with lukewarm water for 1 day Kulattha yush 40 ml in late afternoon Once in a day orally for 1 day Day 3 of delivery Panchkol churna siddha Yavagu 48 ml BD for 1 day Day 4 of delivery Chaturjat churna siddha Yavagu 48 ml BD for 1 day Day 5 of delivery Shaali Shashtik Audana according to appetite of Sutika Day 6 to Day 10 Same as Day 5 |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Sutika aged between 20-35 years
Primi or Multipara women with Full term normal delivery (Beyond 37 weeks of gestational) who are willing to take part in the study and ready to sign informed written consent form .
Delivered with or without Episiotomy.
|
|
| ExclusionCriteria |
| Details |
Who delivered with the Lower segment caesarian section.
Parturient with history of Eclampsia, PPH.
Patient with known case of Hyper/hypotension, Hyper/hypoglycemia or any other disease.
Gestational diabetes mellitus, IUD, Still birth, APH.
Severe anemia( ≤7 gm/dl).
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Beneficial To Postnatal Female |
10 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Prevention from Sutika roga like Sutika udarshoola, Sutika jwar, Stanyakshaya |
10 days |
|
|
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
20/01/2020 |
| 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
|
Will be done after completion of trial |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Puerperium is the period following childbirth during which the body tissues, especially the pelvic organs revert back approximately to the pre pregnant state both anatomically and physiologically. According to Acharya Kashyap "After delivery of the child a female is not called Sutika until the placenta is delivered i.e. only after the expulsion of placenta a woman can be called Sutika. There are different opinion of the duration of this period (Sutika kala), which is ranges from 6 weeks to 6 months. India has a high Maternal Mortality Rate of 167 per 1,00,000 live births and about 15 % Maternal Mortality are caused by Puerperal Sepsis. The proper and scientific management of Sutika is described by all our acharyas in the Ayurvedic science under the caption of Sutika Paricharya. A whole attention which is provided to the female who has delivered an infant should be called ‘Sutika Paricharya’. Care of the Sutika, her diet and its regimen should be done very carefully because if there is any disease in this period than it can be cured with great distress, because of the fetal growth all Dhatus of her body are decrease and because of labour pain, amniotic fluid secretion and bleeding the whole body becomes very weak so its care should be taken strictly. Proper restoration of body physiology is aim of Sutika paricharya.So Prajata care kit is designed as according to the versions of Acharya Harita to give a better and systematic nutrition in puerperal female in a short interval and to regain her energy.
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