| CTRI Number |
CTRI/2017/05/008524 [Registered on: 09/05/2017] Trial Registered Retrospectively |
| Last Modified On: |
20/04/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Episiotomy wound n wound at perineal region |
|
Scientific Title of Study
|
A Controlled Comparative clinical Study of Efficacy of Bala Taila in the Management of Episiotomy Wound |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
trupti awagan |
| Designation |
pg scholar |
| Affiliation |
parul institute of ayurved |
| Address |
pg scholar 3rd year department of stree roga and prasuti tantra 2nd floor
Parul institute ofAyurved
P.O. limda
Ta- Waghodia
Dist-Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
7588879541 |
| Fax |
|
| Email |
truptiawagan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr ranjana ingale |
| Designation |
Reader |
| Affiliation |
parul institute of ayurved |
| Address |
Reader Department of stree roga and prasooti tantra 2nd floor
Parul institute ofAyurved
P.O. limda
Ta- Waghodia
Dist-Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9909945110 |
| Fax |
|
| Email |
ranjanaingale7396@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
trupti Awagan |
| Designation |
Pg scholar |
| Affiliation |
parul institute of ayurved |
| Address |
pg scholar streeroga prasooti tantra department 2nd floor
Parul institute ofAyurved
P.O. limda
Ta- Waghodia
Dist-Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
7588879541 |
| Fax |
|
| Email |
awagantrupti@gmail.com |
|
|
Source of Monetary or Material Support
|
| PARUL INSTITUTE OF AYURVED LIMDA
dist VADODARA 391760 |
|
|
Primary Sponsor
|
| Name |
Parul Institute of Ayurved |
| Address |
Parul institute of Ayurved P.o. Limda Ta. waghodia Dist-Vadodara 391760
|
| Type of Sponsor |
Private medical college |
|
|
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 |
| Trupti M Awagan |
PARUL AYURVED HOSPITAL |
Parul Institute of Ayurved,P.O.Limda,TA.Waghodia, Dist.Vadodara-391760
Vadodara
GUJARAT |
07588879541
Awagantrupti@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PIA-IECHR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
patient having episiotomy wound, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bentadine ointment |
Site- Margins of wound- upto 7 days according to wound size |
| Intervention |
Bala Taila |
Site- Margins of wound- upto 7 days according to wound size |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1 Primipara patients who undergo vaginal delivery with episiotomy will be selected.
2 Patient between ages 20 to 35 will be selected.
3 No history of disease impaired wound healing.
4 Those patient who ready to sign the inform consent form will be included only.
|
|
| ExclusionCriteria |
| Details |
1 Multipara.
2 Patients with 3rd and 4th degree perineal tear or injury to rectum / urethra
3 Patients with any other major illnesses e.g. HIV, HbSAg, VDRL positive,cancer.
4 Patients with history of delayed wound healing, IDDM, gestational diabetes, congenital bleeding disorders.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Standardized REEDA Scale (Redness, Edema, Ecchymosed, Discharge and Approximation) and Numerical Rating Scale (NRS) (‘0-10’ point pain intensity scale) |
within 10 days outcome assessed |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in Standardized REEDA Scale (Redness, Edema, Ecchymosed, Discharge and Approximation) and Numerical Rating Scale (NRS) (‘0-10’ point pain intensity scale) |
within 10 days outcome assessed |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
16/06/2016 |
| 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) |
Open to Recruitment |
|
Publication Details
|
yet none |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Episiotomy is common procedure in obstetric practice. Incidence is 56% in india. There is scope to control pain and wound healing through ayurvedic medicine. Drug use in this study has properties like wound healing, antiinflammatory and analgesic. By using standard scales assessment done. |