| CTRI Number |
CTRI/2021/09/037010 [Registered on: 30/09/2021] Trial Registered Prospectively |
| Last Modified On: |
30/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
A study to compare the effectivity of tila taila snehana and eranda nirgundi sarvang swedan with regular sutika chikitsa in sutikavashtha |
|
Scientific Title of Study
|
A comparative clinical trial to evalute efficcacy beween tila taila snehana and erand nirgundi sarvang swedana with PNC chikitsa in sutikavastha |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Priyanka Sunil Chaudhari |
| Designation |
PG scholar |
| Affiliation |
Sumati Bhai shah ayurved mahavidyala |
| Address |
Sane Guruji Arogya kendra,PG girls hostel, room no. 206, Department of streerog evun prasutitantra,Malwadi, Hadapsar, Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
8888553784 |
| Fax |
|
| Email |
drpriyanka5790@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MANDA S GHORPADE |
| Designation |
HOD |
| Affiliation |
SUMATIBHAI SHAH AYURVEA COLLEGE |
| Address |
DEPT OF STRIROGA PRASUTITANTRA
SUMATIBHAI SHAH AYURVEDA MAHAVIDYALAYA
MALWADI HADAPSAR PUNE
Pune
MAHARASHTRA
411028
India |
| Phone |
9822007570 |
| Fax |
|
| Email |
mandaghorpade@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR MANDA S GHORPADE |
| Designation |
HOD |
| Affiliation |
SUMATIBHAI SHAH AYURVEA COLLEGE |
| Address |
DEPT OF STRIROGA PRASUTITANTRA
SUMATIBHAI SHAH AYURVEDA MAHAVIDYALAYA
MALWADI HADAPSAR PUNE
Pune
MAHARASHTRA
411028
India |
| Phone |
9822007570 |
| Fax |
|
| Email |
mandaghorpade@yahoo.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF STRIROGA PRASUTITANTRA
SANE GURUJI AROGYA KENDRA
MALWADI HADAPSAR PUNE |
|
|
Primary Sponsor
|
| Name |
Dr Priyanka Sunil Chaudhari |
| Address |
PG girls hostel Sane Guruji Arogya kendra, Malwadi, Hadapsar Pune, Department of streerog evum prasutitantra sane Guruji Aarogya kendra Hadapsar Pune |
| Type of Sponsor |
Other [] |
|
|
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 Priyanka Sunil Chaudhari |
Sane Guruji Arogya kendra |
Department of streerog evum prasutitantra Sane Guruji Arogya kendra Malwadi Hadapsar Pune
Pune
MAHARASHTRA |
8888553784
drpriyanka5790@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O909||Complication of the puerperium, unspecified. Ayurveda Condition: Sutika chikitsa, (2) ICD-10 Condition: O920||Retracted nipple associated with pregnancy, the puerperium, and lactation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Regular PNC chikitsa with snehan swedan |
Regular PNC chikitsa with Eranda Nirgundi patra sarvang swedan |
| Intervention |
Tila taila and Eranda Nirgundi patra |
80ml Tila taila will be used for snehana for 4 days
And Erand Nirgundi will be used for sarvang swedan |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
PRIMI WITH FULL TERM NORMAL DELIVERY |
|
| ExclusionCriteria |
| Details |
DELIVERED WOMEN WITH OTHER SYSTEMIC DISEASES LIKE DM, HTN, BA, SKIN ISEASES
LSCS
ANAEMIA |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the efficacy of tila taila snehan and Eranda Nirgundi patra sarvang swedan in sutika awastha |
To study the efficacy of tila taila snehan and Eranda Nirgundi patra sarvang swedan in sutika awastha for 8 days after delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the efficacy of tila taila snehan and Eranda Nirgundi patra sarvang swedan in sutika awastha |
8 days |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
15/10/2021 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NOT APPLICABLE |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
TITLE- COMPARATIVE CLINICAL TRIAL TO EVALUATE EFFICACY BETWEEN TILA TAIL SNEHANA AND ERANDA NIRGUNDI SARVANG SWEDANA WITH PNC CHIKITSA IN SUTIKAVASTHA. SAMLING METHOD- LOTTERY METHOD TOTAL SAMPLE - 120 INCLUSION CRITERIA - PRIMIPARA WITH FULL TERM NORMAL DELIVERY EXCLUSION CRITERIA- DELIVERED WOMEN WITH OTHER SYSTEMIC DISEASE SUCH AS DM, HTN, BA, STI, SKIN DISEASE ANEMIA |