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CTRI Number  CTRI/2022/08/044914 [Registered on: 25/08/2022] Trial Registered Prospectively
Last Modified On: 24/08/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Study of guduchyadi kwatha sadhita karpasa kosha bandha in management of episiotomy wound 
Scientific Title of Study   An Open Label Single Arm clinical trial to evaluate the effect of Guduchyadi Kwatha Sadhita Karpasa Kosha Bandha in episiotomy wound  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ashritha Shetty 
Designation  PG Scholor Department of Prasuti tantra and Stri roga 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital 
Address  Department of Prasuti tantra and Stri roga Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital BM road Thanniruhalla Hassan Karnataka 573201
Thannirhalla
Hassan
KARNATAKA
573201
India 
Phone  07760645169  
Fax    
Email  vasanthshetty875@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Gayathri Bhat N V 
Designation  Professor Department of Prasuti tantra and Stri roga 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital 
Address  Department of Prasuti tantra and Stri roga Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital BM road Thanniruhalla Hassan Karnataka 573201

Hassan
KARNATAKA
573201
India 
Phone  9844437917  
Fax    
Email  gaya3hassan@gmail.com  
 
Details of Contact Person
Public Query  
Name  Ashritha Shetty 
Designation  PG Scholor Department of Prasuti tantra and Stri roga 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital 
Address  Department of Prasuti tantra and Stri roga Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital BM road Thanniruhalla Hassan Karnataka 573201
Thannirhalla
Hassan
KARNATAKA
573201
India 
Phone  07760645169  
Fax    
Email  vasanthshetty875@gmail.com  
 
Source of Monetary or Material Support  
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital  
 
Primary Sponsor  
Name  Dr Ashritha Shetty K 
Address  Department of Prasuti tantra and Stri roga Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM road Thanniruhalla Hassan Karnataka 573201 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ashritha Shetty K  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital  OPD no.20 Department prasuti tantra and Stri roga Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM road Thanniruhalla Hassan Karnataka 573201
Hassan
KARNATAKA 		 7760645169

ashrithashetty1408@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL, HASSAN  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O860||Infection of obstetric surgical wound, (2) ICD-10 Condition: O860||Infection of obstetric surgical wound, (3) ICD-10 Condition: O860||Infection of obstetric surgical wound, (4) ICD-10 Condition:O908||Other complications of the puerperium, not elsewhere classified. Ayurveda Condition: VITAPA-CHEDA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-koSabandhaH, कोषबन्धः (Procedure Reference: Sushruta Samhita Sutrasthana chapter 18, Procedure details: Parisheka with sukhoshna jala drying the perineal area with sterile gauze piece. sterile guduchyadi kwatha sadhita kosha 1 BD Duration- 15 days)
(1) Medicine Name: Guduchyadi kwatha sadhita karpasa koshabandha, Reference: Anubhuta Yoga, Route: Topical, Dosage Form: Not Applicable, Dose: 1(NA), Frequency: bd, Duration: 15 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1. All Primi and Multi Gravida with episiotomy irrespective of age.
2. Those who are ready to sign the informed and written bilingual consent form (Kannada and English)
 
 
ExclusionCriteria 
Details  1. Systemic disorders like diabetes mellitus, hypertension.
2. Subjects with skin diseases.
3. Subjects tested positive for HIV, HBsAg, VDRL
4. History of impaired wound healing.
5. Subjects with perineal hematoma or abscess.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the effect of Guduchyadi Kwatha Sadhita Karpasa Kosha Bandha in wound healing of episiotomy wound, in a course of 15 days of treatment.  Wound healing property of the preparation will be assessed.
Duration of assessment- 15 days 
 
Secondary Outcome  
Outcome  TimePoints 
Wound swab culture will be done to assess, the presence of any infection  Duration of assessment- 15 days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   30/08/2022 
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   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

NAME OF THE DEPARTMENT- DEPARTMENT OF PRASUTI TANTRA EVUM STRIROGA

NAME OF THE STUDENT- Dr. ASHRITHA SHETTY K

NAME OF THE GUIDE- Dr.GAYATHRI BHAT N V

TITLE OF THE STUDY-AN OPEN LABEL SINGLE ARM CLINICAL TRIAL TO EVALUATE THE EFFECT OF GUDUCHYADI KWATHA SADHITA KARPASA KOSHA BANDHA IN EPISIOTOMY WOUND.

SUMMARY-

 

A surgically planned incision on the perineum and posterior vaginal wall during second stage

of labour is called Episiotomy.As the perineum is highly susceptible to infection due to different

secretions like vaginal discharges,faeces and urine, episiotomy wound requires a  proper care as

puerperal sepsis is one of the most common complications of episiotomy which may add to

 maternal mortality and morbidity.

 

In practice anti-biotic and anti- inflammatory drugs are used for treatment of

episiotomywound.Some puerpura may have allergic reactions, gastritis etc effects by these

drugs and cause different health problems in breast fed infants.   Hence  there  is a need to find

an herbal remedy which acts as  anti-inflammatory  and analgesic and promotes wound healing.

 

Episiotomy wound can be compared to chinnavrana (a type of sadhyovrana) and so its

treatment can be inferred as that of sadhyovrana .Sadhyochinnavrana should be managed by

vranahara,shothahara and shulahara drugs. The drugs selected for this study ieGuduchi, Haridra

and Triphala are having these properties and also they are proved to be anti- inflammatory and

analgesic.

 

There are sterile pads available in the market for the  dressing of the wound with wound

healing properties.  Instead of using tropical  applications, it is preferable to use sterile bandages

which will be helpful in preventing wound infection and contamination of wound by faeces and

urine. Bandha is one among ShastiUpakramamentioned for vranachikitsa by Acharya

Shusruta.Considering the above facts, episiotomy care with Guduchyadikwathasadhitakarpasa

bandha kosha is selected for present study which is sterile in the sizeof 6*4 cm  applied

twice daily for 7 days and assessment will be done on 3rd, 7th and 15th day.

 

 

 

                                                                                                

1.      OBJECTIVES- Clinical study to evaluate the effect of Guduchyadikwathasadhitakarpasa kosha bandha in episiotomy wound.

 

METHODOLOGY: Interventional clinical study

RESEARCH DESIGN

Open labeled singlearm  clinical trial.

 SOURCE OF DATA: Patients fulfilling diagnostic and inclusion criteria will be recruited from the inpatient Department ofprasuti tantra evumstriroga, Sri DharmasthalaManjunatheshwara College of Ayurveda and Hospital, Hassan.

SAMPLING TECHNIQUE:  Convenient sampling 

SAMPLE SIZE: 30

 

DIAGNOSTIC CRITERIA:  Parturient women with Episiotomy wound without perineal tear will be considered for the study.

 

INCLUSION CRITERIA:

·         All Primi and Multi Gravida irrespective of age.

·         Those who are ready to sign the informed and written bilingual consent form.

 

Exclusion Criteria:

·         Subjects tested positive for HIV,,HBsAg, VDRL.

·         Systemic diseases like Diabetes mellitus, Hypertension.

·         Subjects with skin diseases.

·         History of impaired wound healing.

·         Subjects with perineal hematoma or abscess.

 

Assessment criteria :

 

1.      Subjective Parameter – Defence and Veterans Pain Rating Scale( DVPRS ) ( Grade 0-10 point pain intensity scale , before and after treatment ) to measure the intensity of :

•         Perineal pain

•         Itching

•         Burning sensation

 

2.      Objective Parameters:

·         Tenderness

·         Odour

·         Inflammation

 The standardized REEDA scale

•         Redness

•         Edema

•         Ecchymosed

•         Discharge

•         Approximation

 

 

 

 


 
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