| CTRI Number |
CTRI/2025/07/090675 [Registered on: 10/07/2025] Trial Registered Prospectively |
| Last Modified On: |
10/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Healing episiotomy wound with ayurveda:A study on the effectiveness of Yashtimadhu siddha ghrit application. |
|
Scientific Title of Study
|
Assessment of the Efficacy of Local Aplication Of Yashtimadhu Siddha Ghrit in Vitapchhed Vrana with special reference to Episiotomy Wound: Randomized Control Trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pragati Pradip Mulik |
| Designation |
PG Scholar |
| Affiliation |
PMTs Ayurved College, shevgaon. |
| Address |
OPD no. 107, PTSR department, Shri eknath ayurved rugnalay, PMTs Ayurved College, shevgaon, tal- shevgaon, dist-ahmadnagar. OPD NO. 107, PTSR department, shri eknath ayurved rugnalay, PMTs Ayurved College, shevgaon, tal- shevgaon, dist-ahmadnagar. Ahmadnagar MAHARASHTRA 414502 India |
| Phone |
7218050186 |
| Fax |
|
| Email |
mulikpragati4@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr prakash Kanade |
| Designation |
Professor and HOD |
| Affiliation |
PMTs Ayurved College, shevgaon. |
| Address |
PMTs Ayurved College, shevgaon, tal- shevgaon, dist-ahmadnagar. PMTs Ayurved College, shevgaon, tal- shevgaon, dist-ahmadnagar. Ahmadnagar MAHARASHTRA 414502 India |
| Phone |
9881413123 |
| Fax |
|
| Email |
prkanade73@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr prakash Kanade |
| Designation |
Professor and HOD |
| Affiliation |
PMTs Ayurved College, shevgaon. |
| Address |
OPD no. 107, PTSR department, Shri eknath ayurved rugnalay, PMTs Ayurved College, shevgaon, tal- shevgaon, dist-ahmadnagar. OPD no. 107, PTSR department, Shri eknath ayurved rugnalay, PMTs Ayurved College, shevgaon, tal- shevgaon, dist-ahmadnagar. Ahmadnagar MAHARASHTRA 414502 India |
| Phone |
9881413123 |
| Fax |
|
| Email |
prkanade73@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD NO. 107, STREERAG AND PRASUTITANTRA DEPARTMENT, SHRI EKNATH AYURVED RUGNALAYA,PMTs Ayurved College shevgaon,tal- shevgaon, dist-ahmadnagar.414502 |
|
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Primary Sponsor
|
| Name |
PMTs Ayurved College, Shevgaon |
| Address |
Shevgaon,Tal-Shevgaon,Dist-Ahmadnagar, Maharashtra414502 |
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pragati Pradip Mulik |
PMTs Ayurved College, Shevgaon |
OPD no. 107, PTSR department, Shri eknath ayurved rugnalay, PMTs Ayurved College, shevgaon, tal- shevgaon, dist-ahmadnagar. Ahmadnagar MAHARASHTRA |
7218050186
mulikpragati4@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O94-O9A||Other obstetric conditions, not elsewhere classified. Ayurveda Condition: VITAPA-MARMAVIDDHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: yashtimadhu siddha ghrit, Reference: yogratnakar sdhyovrana chikitsa 4, Route: Topical, Dosage Form: Ghrita, Dose: 5(g), Frequency: bd, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 7 Days, Reference: No, Route: -, Dosage Form: Ghrita, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Nimba Tail, Reference: kaiyadeva nighantu 4, Route: Topical, Dosage Form: Dravaka, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 7 Days, Reference: No, Route: -, Dosage Form: Dravaka, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: |
|
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Inclusion Criteria
|
| Age From |
22.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
All primi & multigravida whounderwent vaginal delivery with episiotomy. Patients have first and second degree perineal tear. |
|
| ExclusionCriteria |
| Details |
Systemic disorders in pregnency like DM, HTN, pulmonary TB, impaired thyroid functions. patients with third and fourth degree perineal tears. patients with serology positive for HIV, VDRL, HBsAG. patients having perineal haematoma or abscess. |
|
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Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of Yashtimadhu siddha ghrit in episiotomy wound. |
7 days treatment with 9 follow up on 1,2,3,4,5,6,7,10 & 15th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the effect of Nimba tail in episiotomy wound.
To compare the effect of yashtimadhu siddha ghrit and nimba tail in episiotomy wound healing.
To observe adverse effect of drugs during the procedure. |
7 days treatment with 9 follow up on 1,2,3,4,5,6,7,10 & 15th day. |
|
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Target Sample Size
|
Total Sample Size="72" Sample Size from India="72"
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)
|
25/07/2025 |
| 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="0" 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
|
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Brief Summary
|
|
Episiotomy is
planned surgical incision given in the medial or medio-lateral aspect of the
perineum to reduce the maternal and neonatal trauma and morbidity associated
with delivery. It has short term benefits of episiotomy for doctors is easy
to repair compared to a spontaneous perineal lacerations. It also decreases
postpartum pain and reduction in severe or 3rd and 4th
degree perineal tears. Now days the term episiotomy comes into Conside- ration
because the perineal tears can gives many complications, like infection,
sepsis. But healing becomes problematic even after suturing (as the vaginal
PH becomes alkaline in post partum period acc. to modern science) there may
be soiling by fecal matter and gives complications.The degree of
perineal pain and discomfort associated with preineal tear is often underestimated. Pain often interferes with basic daily activities of the woman such as
walking, sitting and act of micturition and that of defecation and also
negatively impact on motherhood experiences. Hence a timely intervention of
episiotomy can prevent the maternal morbidity.
During post natal
period, puerperal sepsis is one of the major concern. As the perineum is
highly susceptible to infection due to different secretions like vaginal
discharges, faeces and urine, episiotomy wound requires a proper care which
could otherwise be self limiting due to high vascularity of perineal area. If not taken care , episiotomy wound may lead to
immediate complications like infection, dehiscence or remote complications
like dyspareunia, scar endometriosis or chances of perineal lacerations in
subsequent labour.
|
Episiotomy
wound can be compared to Chhina Vrana(a type of Sadhyo
Vran) and treatment can be planned as that of sadhyo
vran. Acharya Sushruta has mentioned Shashti Upakrama for Vrana
Chikitsa for better healing and pain management, where alepana being one among them.
|
Thus, a sincere
attempt has been made in the present study to hasten the rate of episiotomy
wound healing by application of Yashtimadhu Siddha Ghrit.
|
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