Study of guduchyadi kwatha sadhita karpasa kosha bandha in management of episiotomy wound

Phase 2/3

Not yet recruiting

• Conditions: 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,

• Registration Number: CTRI/2022/08/044914
• Lead Sponsor: Dr Ashritha Shetty K

Brief Summary

NAME OF THE DEPARTMENT- DEPARTMENT OF PRASUTI TANTRAEVUM 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 TOEVALUATE THE EFFECT OF GUDUCHYADI KWATHA SADHITA KARPASA KOSHA BANDHA INEPISIOTOMY WOUND.

SUMMARY-

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

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

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

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

maternalmortality and morbidity.

 In practice anti-biotic and anti- inflammatory drugsare used for treatment of

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

drugs and cause different health problems in breastfed 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 (atype of sadhyovrana) and so its

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

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

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

analgesic.

 There are sterile pads available in the market forthe  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 infectionand contamination of wound by faeces and

urine. Bandha is one among ShastiUpakramamentionedfor vranachikitsa by Acharya

Shusruta.Considering the above facts, episiotomycare with Guduchyadikwathasadhitakarpasa

bandha kosha is selected for present study which is sterilein the sizeof 6\*4 cm  applied

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

   1.     OBJECTIVES**-** Clinical study to evaluate the effect ofGuduchyadikwathasadhitakarpasa kosha bandha in episiotomy wound.

 METHODOLOGY**:** Interventional clinical study

RESEARCHDESIGN

Open labeled singlearm  clinical trial.

SOURCEOFDATA**:** Patients fulfilling diagnostic and inclusion criteria will berecruited from the inpatient Department ofprasuti tantra evumstriroga, SriDharmasthalaManjunatheshwara College of Ayurveda and Hospital, Hassan.

SAMPLINGTECHNIQUE**:**  Convenient sampling

SAMPLESIZE: 30

DIAGNOSTIC CRITERIA:  Parturient women with Episiotomy woundwithout perineal tear will be considered for the study.

INCLUSIONCRITERIA**:**

·        All Primi and MultiGravida irrespective of age.

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

 ExclusionCriteria**:**

·        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.

 Assessmentcriteria **:**

 1.     Subjective Parameter – Defence andVeterans 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.     ObjectiveParameters**:**

·        Tenderness

·        Odour

·        Inflammation

ThestandardizedREEDAscale

•        Redness

•        Edema

•        Ecchymosed

•        Discharge

•        Approximation

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-08-24
• Study Start: 2022-08-30

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• All Primi and Multi Gravida with episiotomy irrespective of age.
• Those who are ready to sign the informed and written bilingual consent form (Kannada and English).

Exclusion Criteria

• Systemic disorders like diabetes mellitus, hypertension.
• Subjects with skin diseases.
• Subjects tested positive for HIV, HBsAg, VDRL 4.
• History of impaired wound healing.
• Subjects with perineal hematoma or abscess.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
Wound swab culture will be done to assess, the presence of any infection	Duration of assessment- 15 days

Trial Locations

Locations (1)

Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital; 🇮🇳 Hassan, KARNATAKA, India

Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital

🇮🇳Hassan, KARNATAKA, India

Dr Ashritha Shetty K

Principal investigator

7760645169

ashrithashetty1408@gmail.com