| CTRI Number |
CTRI/2025/07/090016 [Registered on: 02/07/2025] Trial Registered Prospectively |
| Last Modified On: |
01/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To see the Effect of Shatpushpa Taila in vaginal injury during normal delivery |
|
Scientific Title of Study
|
Randomized clinical control trial on efficacy of shatpushpa taila in vitapched janya vrana seevan karma pradesh with special reference to 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 Anjali Laxman Bagal |
| Designation |
PG Scholar |
| Affiliation |
Shree Saptashrungi ayurved mahavidyalaya and hospital Kamal nagar Hirawadi Panchavati Nashik |
| Address |
Department of prasuti tantra and strirog
OPD no 4 Ground floor Shree Saptashrungi ayurved mahavidyalay and hospital Nashik Kamal nagar panchavati Nashik
Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
9767320603 |
| Fax |
|
| Email |
anjalibagal3335@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Varsha Suresh Deshmukh |
| Designation |
Professor |
| Affiliation |
Shree Saptashrungi ayurved mahavidyalaya and hospital Kamal nagar Hirawadi Panchavati Nashik |
| Address |
Deshmukh niwas Ramwadi Baijabaichi chhavani Panchavati Nashik
Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
9403513983 |
| Fax |
|
| Email |
varshasdeshmukh15@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Varsha Suresh Deshmukh |
| Designation |
Professor |
| Affiliation |
Shree Saptashrungi ayurved mahavidyalaya and hospital Kamal nagar Hirawadi Panchavati Nashik |
| Address |
Deshmukh niwas Ramwadi Baijabaichi chhavani Panchavati Nashik
Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
9403513983 |
| Fax |
|
| Email |
varshasdeshmukh15@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shree Saptashrungi ayurved mahavidyalaya and hospital Kamal nagar Panchavati Nashik 422003 |
|
|
Primary Sponsor
|
| Name |
Dr Anjali Laxman Bagal |
| Address |
Department of Prasuti tantra and strirog
OPD no 4 ground floor
Shree Saptashrungi Ayurved
Mahavidyalaya And Hospital kamal nagar panchavati Nashik 422003 India
|
| 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 |
| Dr Anjali Laxman Bagal |
Shree Saptashrungi Ayurved Mahavidyalaya And Hospital Nashik |
Department of Prasuti tantra and strirog OPD no 4 Ground floor
Shree Saptashrungi Ayurved Mahavidyalaya And Hospital kamal nagar Panchavati nashik 422003
Nashik
MAHARASHTRA |
9767320603
anjalibagal3335@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Shree saptashrungi ayurved mahavidyalaya kamla nagar panchavati nashik |
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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shatpushpa, Reference: Bhaishajya ratnavali yoni vyapad chikitsa prakaran shlok no 17, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: qid, Bhaishajya Kal: Muhurmuhu, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: Local application of shatpushpa taila on episiotomy wound |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Patient who has undergone episiotomy procedure of any parity will be selected |
|
| ExclusionCriteria |
| Details |
Perineal tear
Patient having blood coagulopathy
Prolonged labor PPH
Patient suffering from Diabetes mellitus Hypertension etc
VDRL HBSaG positive patients
Having history of episiotomy complications in previous delivery example keloid gap resuturing |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| signs of episiotomy wound healing within 7 days of start of treatment |
signs of episiotomy wound healing within 7 days of start of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Complete healing of episiotomy wound in 21 days of start of treatment |
Complete healing of episiotomy wound in 21 days of start of treatment |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
15/07/2025 |
| 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="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
|
Randomized clinical control trial on efficacy of Shatpushpa taila in vitapched janya vrana seevan karma pradesh with special reference to episiotomy wound Primary objective To study the efficacy of Shatpushpa taila in vitapched janya vrana seevan karma pradesh wsr episiotomy wound Secondary objective To study the literature regarding episiotomy To study properties of Shatpushpa To study the efficacy of Shatpushpa tail against povidone iodine ointment Patients will be divided in two groups Group A and Group B and will be given Shatpushpa taila local application and povidone iodine ointment local application respectively for 15 days Clinical assessment will be done on day 1 day 3 day 7 day 14 day 21 Inclusion criteria age 20 to 35 years Patient who has undergone episiotomy procedure of any parity will be selected Exclusion criteria Perineal tear Patient having blood coagulopathy Prolonged labor PPH Patient suffering from Diabetes mellitus Hypertension etc VDRL HBSaG positive patients Patients having history of episiotomy complications in previous delivery example Keloid Gap Resuturing Withdrawal criteria Occurence of serious adverse event of any cause If patient want to withdraw her from this experiment If patient absent for follow up will be considered as dropped from this project Primary outcome Presence of signs of healing of episiotomy wound in 7 days of start of treatment Secondary outcome Complete healing of episiotomy wound in 21 days of start of treatment All data will be collected from clinical case studies will be presented in the form of graph charts healing grade Patients will be observed before and after treatment All observed data collected after the final assessment will be subjected to statistical analysis
|