A study for comparison between kshar application & sclerobanding in grade 2 internal haemorrhoids

Phase 3

Not yet recruiting

• Conditions: Second degree hemorrhoids. Ayurveda Condition: ARSAH,

• Registration Number: CTRI/2023/11/059402
• Lead Sponsor: DrYogita Patel

Brief Summary

**TITLE OF DISSERTATION**

**A COMPARATIVE CLINICAL STUDY TO ASSESS THE ROLE OF PRATISARNEEYA KSHAR AND SCLEROBANDING IN THE MANAGEMENT OF ABHYANTRAR ARSHA W.S.R. TO GRADE 2 INTERNAL HAEMORRHOIDS**

 **AIM**

A comparative clinical study to assess the role of PratisaraneeyaKshar and Sclerobanding in the management of AbhyantarArshaw.s.r. to Grade 2 internal haemorrhoids.

**OBJECTIVES**

To assess the efficacy of *PratisaraneeyaKshar* in the management of *AbhyantarArsha* such as bleeding per rectum size of pile pedicle, colour of pile pedicle, constipation, pain.

To assess the efficacy of Sclerobanding in the management of Grade 2 Internal Haemorrhoids.

To assess the efficacy of *PratisaraneeyaKshar* in the Grade 2 Internal Haemorrhoids.

To compare the efficacy of *PratisaraneeyaKshar* with Sclerobanding in the management of Grade 2 Internal Haemorrhoids.

**RESEARCH QUESTION**

*Pratisaraneeyakshar* is equal/more effective than Sclerobanding in the management of Grade 2 Internal Haemorrhoids?

**HYPOTHESIS**

**NULL HYPOTHESIS (H0)**: *PratisaraneeyaKshar* is not effective than Sclerobanding in the management of Grade 2 Internal Haemorrhoids.

**ALTERNATIVE HYPOTHESIS (H1)**: *PratisaraneeyaKshar* is effective than Sclerobanding in the management of Grade 2 Internal Haemorrhoids

**MATERIALS & METHODS**

 SOURCE OF DATA- D.Y Patil Ayurvedic Hospital, Navi Mumbai, Shalya Tantra department, OPD No- 03

**Type of study-** Comparative clinical study

**Ethical clearance**- Ethical clearance will be taken from ethical committee of D.Y Patil Ayurvedic Hospital.

**Consent-**

An understanding will be given to the patients about trial and a written consent will be taken from the patient prior to participate in the study.

**Sample size**- 60 patients will be randomly divided into two groups with 30 patients in each group.

**Material/Drug-**

Group A:- *Apamargaksharapratisaran*

Group B:- Rubber band ligation by Barron Pile Gun followed by  Injection Polidicanol 3%

**Doses –**

Local application of*patikshareeyakshar*on each pile mass

Injection Polidocanol 3% 2 to 3cc of foam in each pile mass

**Follow up-**

On the day of procedure followed by 1st day,3rd day,5th day,7th day,14th day,21st day,28thday after application of *kshar*or Sclerobanding

Duration of study- 1month

**METHODOLOGY**

Group A: 30 patients will be treated by ApamargaKsharPratisaran which will be prepared from    panchang of Apamarga.

Group B: 30 patients will be treated with Inj.Polidocanal 3% foam after doing rubber band ligation.

**PROCEDURE**:  All the pre operative and post operative protocols will be followed in both the groups. Both the procedures will be done under spinal anesthesia.

**Prepration of Pratisaraneeyakshara:**

Pratisaraneeyakshar was prepared using the ash of the plant Apamarga(panchang*). Apamarga* ash was mixed with 6th part of distilled water stirred well and was left over night. Next morning the solution was filtered with whatmann’s filter paper to obtain a clear solution.The filtrate was evaporated at 120-1300 C to obtain*kshar.*

Group A – The Patient will be placed in the lithotomy position.Digital rectal examination and proctoscopy will be done to assess site*,*size and number of the pile masses.The pile mass will be cleaned with normalsaline and dried with dry gauze piece*.Kshar* will be applied with the help of spatula till pile mass become pakvaJambuPhala color after that,the pile mass will be washed with kanji and anal canal will be cleaned.

Group B - The patient will be placed in the lithotomy position. The digital rectal examination and practoscopy will be done to asses site,size and number of the pile masses.Rubber band ligation will be done to the haemmorhoids followed by sclerotherapy ( 3% polidocanol foam will be injected in each haemorrhoids in the quantity of 2cc)

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-11
• Last Update Posted: 2023-10-27

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 1.Diagnosis will be done with the help of video proctoscope 2.patient of second-degree internal haemorrhoids will be included in this study.
• 3.Age group between 18-60 years (irrespective of gender).

Exclusion Criteria

• 1.Patients having Diabetes, 2.
• Malignancies 3.
• HIV positive 4.
• HBsAg positive 5.
• VDRL positive.
• 6.Pregnant women.
• Grade 1 and Grade 3 internal haemorrhoids.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in the clinical symptoms parameter such as per rectal bleeding ,size of pedicle,colour of pedicle, constipation & pain after	Improvement in the clinical symptoms parameter such as per rectal bleeding ,size of pedicle,colour of pedicle, constipation & pain after pre operation ,post operation , 3rd,7th,14th and 28th days

Trial Locations

Locations (1)

DY PATIL Ayurvedic Hospital; 🇮🇳 Thane, MAHARASHTRA, India

DY PATIL Ayurvedic Hospital

🇮🇳Thane, MAHARASHTRA, India

DrYogita Patel

Principal investigator

9158262055

yogitapatel1920@gmail.com