| CTRI Number |
CTRI/2025/03/083442 [Registered on: 26/03/2025] Trial Registered Prospectively |
| Last Modified On: |
27/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the effect of sukshma triphala tablet with local application of medicated ghee with honey on surgical wound taken during vaginal delivery. |
|
Scientific Title of Study
|
Randomized controlled trial to study the efficacy of Sukshma Triphala vati orally and Nimbapatradi ghrita with madhu local application in Episiotomy wound.
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Prajakta Khandoji Shinde |
| Designation |
Pg scholar |
| Affiliation |
Siddhakala ayurved mahavidyalaya sangamner |
| Address |
Ground floor OPD No 5 streeroga and prasuti tantra department siddhakala ayurved mahavidyalaya hospital and research center pimparne road sangamner 422605
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9834644773 |
| Fax |
|
| Email |
prajaktashinde332@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rhuta N Saraf |
| Designation |
Associate professor |
| Affiliation |
Siddhakala ayurved mahavidyalaya sangamner |
| Address |
Third floor streeroga and prasuti tantra department siddhakala ayurved mahavidyalaya hospital and research center pimparne road sangamner
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
8485807070 |
| Fax |
|
| Email |
rhutasaraf@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Prajakta Khandoji Shinde |
| Designation |
Pg scholar |
| Affiliation |
Siddhakala ayurved mahavidyalaya sangamner |
| Address |
Ground floor OPD No 5 streeroga and prasuti tantra department siddhakala ayurved mahavidyalaya hospital and research center pimparne road sangamner 422605
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9834644773 |
| Fax |
|
| Email |
prajaktashinde332@gmail.com |
|
|
Source of Monetary or Material Support
|
| Siddhakala ayurved hospital research center pimparne road sangamner khurd, sangamner, district ahmadnagar, state Maharashtra, country India. pincode-422605 |
|
|
Primary Sponsor
|
| Name |
Dr Prajakta Khandoji Shinde |
| Address |
Ground floor OPD No 5 streeroga and prasuti tantra department siddhakala ayurved mahavidyalaya hospital and research center pimparne road sangamner khurd, Sangamner, Ahmadnagar, Maharashtra, India. pincode-422605 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Prajakta Khandoji Shinde |
Siddhakala ayurved mahavidyalaya |
Ground floor OPD No 5 streeroga and prasuti tantra department siddhakala ayurved mahavidyalaya hospital and research center pimparne road sangamner khurd, Sangamner, Ahmadnagar, Maharashtra, India. Pincodde-422605
Ahmadnagar
MAHARASHTRA |
9834644773
prajaktashinde332@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Board of Ayurved Research and Statistics Committee of Siddhakala Ayurved Mahavidyalaya,Sangamner |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O80||Encounter for full-term uncomplicated delivery. Ayurveda Condition: VRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Tab Cefixime 200mg and povidine iodine ointment | Tab Cefixime 200mg 1 BD for 3 days orally and Povidine Iodine ointmnet locally 2-3gm every 6 hourly for 7 days |
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1.Patient aged between 19-35 years
2.Uncomplicated vaginally delivered patients with episiotomy
3.Patient with first and second-degree perineal tear
4.Patients who give informed consent should involve
5.Patient who follow proper protocol should include |
|
| ExclusionCriteria |
| Details |
1.Patients with labor complications i.e. Extensive perennial tear ,PPH, placental retention etc.
2.Patients of systemic disorders, Instrumental vaginal delivery. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study in detail the rate and extent of Episiotomy wound healing after the oral administration of Sukshma Triphala vati 250mg 2BD for 3 days and local application of Nimbapatradi ghrita with Madhu 2-3 gm every 6 hourly for 7 days. |
At the time of episiotomy taken, on 3rd day and final outcome will be assessed on 7th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To evaluate the reduction of pain and associated symptoms during the intervention period in episiotomy wound.
2.To study episiotomy wound from ayurvedic perspective.
3.To assess any adverse reaction or side effect related to the oral administration of Sukshma Triphala vati or the local application of Nimbapatradi Ghrita with Madhu.
4.To introduce effective ayurvedic medicine for episiotomy wound healing. |
At the time of episiotomy taken, on 3rd day and final outcome will be assessed on 7th day |
|
|
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 |
|
Date of First Enrollment (India)
|
08/04/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Study is randomized open labelled clinical trial to assess effect of Sukshma Triphala vati orally and Nimbpatradi ghrita with madhu local application in Episiotomy wound. Total sample size is 60 There are two groups, and each group has 30 patients Group A is a trial group and Group B is a control group. Group A has Sukshma Triphala vati orally 3 days and Nimbapatradi Ghrita with Madhu local application for 7 days in Episiotomy wound Group B has Tab Cefixime 200mg orally for 3 days and Povidine Iodine ointment local application for 7 days in Episiotomy wound Follow up on - 3rd and 7th day Analysis of data and Interpretition of result.
|