| CTRI Number |
CTRI/2025/07/092070 [Registered on: 31/07/2025] Trial Registered Prospectively |
| Last Modified On: |
31/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparison between durvadi tail plot and jatyadi tail plot in episiotomy wound. |
|
Scientific Title of Study
|
A comparative clinic study in the efficacy of durvadi tail plot and jatyadi tail plot on 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 Shraddha Kantode |
| Designation |
PG Scholar |
| Affiliation |
Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal |
| Address |
P.G. department of Prasuti tantra evum stri roga, O.P.D. No . 08 , Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal
Bhopal
MADHYA PRADESH
462044
India |
| Phone |
09144904021 |
| Fax |
|
| Email |
shraddhakantode9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rakesh Kumar Gupta |
| Designation |
Assistanat Professor In Prasuti Tantra Evum Stree Roga |
| Affiliation |
Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal |
| Address |
P.G. department of Prasuti tantra evum stri roga, O.P.D. No . 08 , Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal
Bhopal
MADHYA PRADESH
462044
India |
| Phone |
9916271722 |
| Fax |
|
| Email |
rakeshk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rakesh Kumar Gupta |
| Designation |
Assistanat Professor In Prasuti Tantra Evum Stree Roga |
| Affiliation |
Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal |
| Address |
P.G. department of Prasuti tantra evum stri roga, O.P.D. No . 08 , Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal
Bhopal
MADHYA PRADESH
462044
India |
| Phone |
9916271722 |
| Fax |
|
| Email |
rakeshk@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rani dullaiya smriti ayurved Pg college & Hospital ,Bhopal, Madhya Pradesh , India ,462044 |
|
|
Primary Sponsor
|
| Name |
Dr Shraddha kantode |
| Address |
P.G scholar ,Prasuti tantra evum stri roga dept , Rani dullaiya smriti ayurved Pg college & Hospital ,Bhopal, Madhya Pradesh , India ,462044 |
| 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 Shraddha Kantode |
Rani dullaiya smriti ayurved Pg college & Hospital ,Bhopal, Madhya Pradesh , India ,462044 |
Department of prasuti tantra evum stri roga ,O.P.D. No . 08 , Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal
Bhopal
MADHYA PRADESH |
7709077352
shraddhakantode9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical comitee , Rani dullaiya smriti ayurveda pg college evam chikitsalaya , Bhopal , M.P |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O701||Second degree perineal lacerationduring delivery. Ayurveda Condition: SUTIK, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: durvadi taila , Reference: bhaisajaya ratnavalli , Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: Durvadi taila in mooladhar kshat varna | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Jatyadi taila , Reference: sharangdhar samhita , Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: -), Additional Information: Jatyadi taila in mooladhar kshat varna |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
patient selected irrespective of cast, religion, habitat, occupation and socio-economic status.
all patients of vaginal delivery with episiotomy.
patients of any parity will be taken. |
|
| ExclusionCriteria |
| Details |
patient with caesarean section
patient with medical and surgical disorder
severely malnourished and anemic patient less than 7 hb value
any bleeding disorder
known case of AIDS , hepattits B ,STD ,VDRL , HCV , HBSag , diabetes |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| efficacy of durvadi taila and jatyadi taila in patients |
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| compare the effect of durvadi taila and jatyadi taila in muladhaar kshat vrana |
14 days |
|
|
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)
|
15/08/2025 |
| 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="0"
Months="10"
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
|
This is a double group, open label, comparative clinical study on the efficacy of Durvadi Taila plota and Jatyadi Taila plota on the muladhaar kshata vrana w.s.r to episiotomy.The primary outcome is to reduce pain, edema and increase wound healing efficiently without scar formation , compare the efficacy of both oil described in classical texts . |