| CTRI Number |
CTRI/2025/01/078841 [Registered on: 16/01/2025] Trial Registered Prospectively |
| Last Modified On: |
30/12/2024 |
| 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
|
Effect of local application of Manjishthadi taila in the management of episiotomy wound. |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Study To Evaluate The Efficacy Of Local Application Of Manjishthadi Taila In The Management Of Vitapa Cheda 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 |
Bhagyashri Bhanudas Patil |
| Designation |
Post Graduate Resident |
| Affiliation |
APMs Ayurved Mahavidyalaya Sion |
| Address |
Department of prasutitantra and strirog 3rd floor APMs Ayurved Mahavidyalaya Sion near sion railway station Mumbai Mumbai 400022
Mumbai
MAHARASHTRA
400022
India |
| Phone |
8830593667 |
| Fax |
|
| Email |
bhagyashri97patil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pallavi Gopal Lamture |
| Designation |
Professor |
| Affiliation |
APMs Ayurved Mahavidyalaya Sion |
| Address |
Department of prasuti tantra evum streeroga APMs Ayurved Mahavidyalaya Sion near sion railway station Mumbai Mumbai 400022
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9819865834 |
| Fax |
|
| Email |
drplamture@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pallavi Gopal Lamture |
| Designation |
Professor |
| Affiliation |
APMs Ayurved Mahavidyalaya Sion |
| Address |
Department of prasuti tantra evum streeroga APMs Ayurved Mahavidyalaya Sion near sion railway station Mumbai Mumbai 400022
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9819865834 |
| Fax |
|
| Email |
drplamture@gmail.com |
|
|
Source of Monetary or Material Support
|
| APMs Ayurved Mahavidyalaya sion near sion railway station sion east 400022 |
|
|
Primary Sponsor
|
| Name |
Bhagyashri Bhanudas Patil |
| Address |
APMs Ayurved Mahavidyalaya sion near sion railway station Sion Mumbai 400022 |
| 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 Bhagyashri Bhanudas Patil |
APMs Ayurved Mahavidyalaya and seth R V Ayurved Hospital Sion Mumbai |
iPD of prasutitantra and strirog APMs Ayurved Mahavidyalaya and seth R V Ayurved Hospital near sion railway station sion Mumbai 400022
Mumbai
MAHARASHTRA |
8830593667
bhagyashri97patil@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| APMs Ayrved Mahavidyalaya sion IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O901||Disruption of perineal obstetric wound. Ayurveda Condition: VITAPA-MARMAVIDDHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Manjishthadi Taila, Reference: Sushruta Samhita Chikitsasthan 2/73,74, Route: Topical, Dosage Form: Taila, Dose: 3(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 10 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Povidone Iodine solution 5% | Route-Topical Dose- 3ml Frequency-bd Duration-10 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.All Primi & Multipara who undergone Normal
vaginal delivery with Episiotomy wound.
2.Age group -18 to 40 years.
3.Voluntary willing patients.
4.Patients irrespective of religion,
cast, socio-economic status, occupation |
|
| ExclusionCriteria |
| Details |
1.Forceps & Vaccum delivery.
2.All degree perineal tears.
3.Patients having perineal hematoma or abscess.
4.Patients having HIV, HBsAg, HCV, VDRL Positive.
5.Patients with DM, HTN
6.Moderate (7-8.9 gm/dl HB) & Severe (less than 7 gm/dl HB ) Anaemic patients. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Standardized REEDA Scale
(REEDA- Redness, edema, ecchymosis, discharge, approximation |
10 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Vrana Vedana -Pain
2.Vrana Shotha -Inflammation
3.Vrana Gandha-Foul smell
4.Vrana Strava -Discharge |
10 days |
|
|
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 4 |
|
Date of First Enrollment (India)
|
01/02/2025 |
| 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
|
In the present times, During vaginal deliveries ,Episiotomy A surgically planned incision on perineum and posterior Vaginal wall during the 2nd stage of labour to facilitate easy & safe Vaginal delivery of baby is routinely administered.
Although in Ayurvedic Samhita, description of Episiotomy wound has not been given directly but vrana (wound) is described very well and hence it can be considered as shuddha Agantuja sadyo vrana or Vaidyakrita vrana and also it can be considered as Sukhsadhya Vrana.
In Ayurveda, Various drugs are mentioned for external application and internal administration in context of vrana.
we can corelate Episiotomy wound with sadhyavrana and if it is left untreated it may lead to dushta vrana which can affect the quality of life.
Postpartum women faces a lot of difficulties in sitting ,walking, standing & urination also, So it is very much necessary that perineum shall be healed as soon as possible to avoid the complications such as pain, swelling, discomfort ,sepsis, discharge which interferes with women’s daily activity.
Manjishthadi taïla acts as Varnya, shothahar, Kledshoshak, Vedanasthapak, kandughna, krumighna, Jantughna because of its Tikta, katu, kashay Rasa So keeping all this in mind Manjishthadi á¹aila is being selected For study. |