| CTRI Number |
CTRI/2020/01/022927 [Registered on: 23/01/2020] Trial Registered Prospectively |
| Last Modified On: |
23/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ayurveda Treatment In Episiotomy Wound Healing |
|
Scientific Title of Study
|
A Controlled Comparative Clinical Study To Evaluate The Efficacy Of Talisadi Malhar In The Management Of Episiotomy Wound Healing |
| Trial Acronym |
Episiotomy |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ANJALI |
| Designation |
PG SCHOLAR |
| Affiliation |
Parul Institute Of Ayurved |
| Address |
Room no.308 Department Of Prasuti Tantra Evum Stree Roga Parul Institute Of Parul University P O Limda Tal Waghodia Vadodara
same as above
Vadodara
GUJARAT
391760
India |
| Phone |
8295829523 |
| Fax |
02668-260201 |
| Email |
anjaliangel.dhull028@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 Parul University P O Limda Tal Waghodia Vadodara
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 Parul University P O Limda Tal Waghodia Vadodara
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 Ayurveda hospital |
| Address |
OP No 104 department of prasuti tantra evum stree roga Parul Institute of Ayurved Parul University PO Limda tal waghodia vadodara Gujarat |
| 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 |
OP NO 104 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 |
| Instituitional Ethics Committee for human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O901||Disruption of perineal obstetric wound, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Betadine ointment |
cleaning the genital organ with lukewarm water then apply 3gm of betadine ointment twice a day for 7 days |
| Intervention |
Talisadi Malhar |
cleaning the genital organ with lukewarm water then apply 3gm of talisadi malhar twice a day for 7 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Parturient women of either primi or multiparous who had full term normal vaginal delivery
with episiotomy will be selected
Patients between age 20 to 35 will be selected Those patients who will be ready to sign the inform consent form will be included |
|
| ExclusionCriteria |
| Details |
3rd and 4th degree perineal tear or injury to rectum or urethra
Patient with Pregnancy induced Hypertension
High risk Pregnancy
Perineal skin infection
Diabetes Mellitus |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Observe the healing of episiotomy wound |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Observe the healing of episiotomy wound |
21 days |
|
|
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
27/01/2020 |
| 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)?
|
|
Brief Summary
|
Episiotomy is a surgical planned incision on the perineum and posterior vaginal wall during second stage of labour.It is the commonest surgical intervention to facilitate the soft tissue outlet for easy
and safe delivery and also to prevent injury to the perineal tear. As a perineum is highly susceptible to infection due to both excretory orifices and different secretions like vaginal discharges, so it is necessary to give proper treatment to the patients.Episiotomy wound can be compared to chhinnavrana (a kind of sadhyovrana), so the treatment can be inferred so that of sadhyovrana. Aalepa is one among shashtiupakurma which has been incorporated in our classics for better wound healing with minimum scar formation.Sushrat has mentioned Talisadiyog as a SadhyovranaRopaka.
Thus in the present study the efficacy of Talisadimalhar will be observed under aseptic precautions and results will be tabulated in dissertation. A Survey conducted among eleven countries including India across the Global Network for Women’s and children’s Health Research sites (2003) reported over 90 per cent episiotomy rates among nullipara through overall rate was about 40 pe cent . The smallness of episiotomy cutbrings us to assume that this operation will not cause problem to the mother, though this area participates in more ordinary activities such as sitting, walking, standingand urination due to availability of many muscles in the pelvic floor and causes discomfort for postpartum women.Hence it is necessary that perineal shall be healed as soon as possible to avoid the complications. Hence, it is evident that special care must be taken to prevent infection. The delay in perineal healing leads to increasing the complications such as bleeding, pain, painful intercourse and anxiety.Timely done episiotomy can prevent cervical tear and Perineal tear. The accuracy in the timing of the episiotomy is also associated with far lesser blood loss. Proper treatment of episiotomy prevents Puerperal sepsis.
In Ayurveda, there are lots of preparation which have good healing property along with antibiotic and antiseptic action. Talisadi malhar is one of them.
|