CTRI Number |
CTRI/2023/05/052787 [Registered on: 17/05/2023] Trial Registered Prospectively |
Last Modified On: |
16/05/2023 |
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
|
A clinical trail to study the effects of Karanja ghrita, Nimbadi ointment and Betadine ointment along with yoni dhoopana in the management of Episiotomy wound |
Scientific Title of Study
|
A randomized comparative clinical study of karanja ghrita, nimbadi ointment and betadine ointment along with yoni dhoopana 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 |
Dr Shweta Chandra |
Designation |
M.S. Scholar |
Affiliation |
National Institute Of Ayurveda , Jaipur |
Address |
Room no 305,Third floor, Department of prasuti tantra evum stri roga, National Institute of Ayurveda, Jorawer singh gate , Amer road ,Jaipur, Rajasthan
Jaipur RAJASTHAN 302002 India |
Phone |
8385832603 |
Fax |
|
Email |
chandrashweta1997@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
DrBPushpalatha |
Designation |
Professor |
Affiliation |
National Institute Of Ayurveda , Jaipur |
Address |
Room no 305, third floor, Department of Prasuti tantra evum stri roga, National Institute of Ayurveda, Jorawer singh gate , Amer road ,Jaipur, Rajasthan
Jaipur RAJASTHAN 302002 India |
Phone |
9413206790 |
Fax |
|
Email |
pushpalathania@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Shweta Chandra |
Designation |
M.S. Scholar |
Affiliation |
National Institute Of Ayurveda , Jaipur |
Address |
Room no 305,third floor, Department of Prasuti tantra evum stri roga, National Institute of Ayurveda, Jorawer singh gate , Amer road ,Jaipur, Rajasthan
Jaipur RAJASTHAN 302002 India |
Phone |
8385832603 |
Fax |
|
Email |
chandrashweta1997@gmail.com |
|
Source of Monetary or Material Support
|
National Institute Of Ayurveda,Zorawer singh gate, Amer road, Jaipur, Rajasthan- 302002 |
|
Primary Sponsor
|
Name |
National Institute Of Ayurveda |
Address |
Jorawer singh gate , amer road , jaipur |
Type of Sponsor |
Government 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 |
Dr Shweta Chandra |
National Institute Of Ayurveda |
Room no 305, third floor, Department of Prasuti tantra evum stri roga, National institute of Ayurveda,Jorawer Singh Gate, amer road, Jaipur, Rjasthan Jaipur RAJASTHAN |
8385832603
chandrashweta1997@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
INSTITUTIONAL ETHICS COMMITTEE NATIONAL INSTITUTE OF AYURVEDA |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:O997||Diseases of the skin and subcutaneous tissue complicating pregnancy, childbirth and the puerperium. Ayurveda Condition: VRANAH, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Comparator Arm | Procedure | - | lepa, लेप | (Procedure Reference: sharangdhara samhita, Procedure details: Nimbadi ointment after episiotomy wound bd after food for 15 days)
| 2 | Comparator Arm (Non Ayurveda) | | - | betadine ointment | application of betadine ointment on episiotomy wound after food bd for 15 days | 3 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: bhavprakash, Procedure details: karanja ghrita aalepa on episiotomy wound after food bd for 15 days)
|
|
|
Inclusion Criteria
|
Age From |
21.00 Year(s) |
Age To |
40.00 Year(s) |
Gender |
Female |
Details |
Both primigravida and multigravida .
Patients who will undergo noramal vaginal delivery with episiotomy.
Patients with 1st and 2nd degree perineal tear
|
|
ExclusionCriteria |
Details |
1. Patients with severe anemia and any systemic disease.
2. Patients with 3rd degree perineal tear.
3. Any skin disease.
4. Patients with positive VDRL, HIV, HBsAg
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
Changes in REEDA scale. |
3 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
not appicable |
not applicable |
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
01/07/2023 |
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
|
none yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Perineal trauma is a major problem affecting millions of
women around the world each year.The degree of perineal pain and discomfort
associated with perineal trauma is often
underestimated. Pain often interferes with daily activites such as walking ,
sitting and passing urine and also negatively impacts on motherhood
experiences. Proper care of episiotomy wound which is already associated with a
lot of pain is very important as the
parineal area is highly contaminated with lochia, faeces and urine.
The improper care of wound
leads to several complications like hemorrhage , incontinence of urine and flatus,
rectovaginal fistula, wound separation, wound site infection, perineal hematoma
,excessive fibrosis etc. Healing by fibrosis may cause dyspareunia and rigid
perineum. These complications leads to both physical and psychological problems
and prevents the mothers from enjoying their motherhood.
While several therapies for wound healing like some solutions
and antibiotics are available but these are only moderately effective. Even
there are many formulations that have failed to achieve the satisfied action
and can cause side effects also.Thus there is a need for more effective
therapies and formulations for healing wounds. |