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CTRI Number  CTRI/2023/11/059402 [Registered on: 01/11/2023] Trial Registered Prospectively
Last Modified On: 27/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study for comparison between kshar application & sclerobanding in grade 2 internal haemorrhoids 
Scientific Title of Study   A COMPARATIVE CLINICAL STUDY TO ASSESS THE ROLE OF PRATISARNEEYA KSHAR AND SCLEROBANDING IN THE MANAGMENT OF ABHYANTRAR ARSHSA WITH SPECIAL REFERENCE TO GRADE 2 INTERNAL HAEMORRHOIDS. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrYogita Patel  
Designation  PG Schollar 
Affiliation  Dr. DY Patil Deemed to be University 
Address  Dr.DY Patil School of Ayurveda, Nerul , Navi Mumbai Department Of Shalya Tantra School Of Ayurveda, DY Patil Deemed to be University,Navi Mumbai
Dr.DY Patil School of Ayurveda, Nerul , Navi Mumbai Department Of Shalya Tantra School Of Ayurveda, DY Patil Deemed to be University,Navi Mumbai
Thane
MAHARASHTRA
400706
India 
Phone  9158262055  
Fax    
Email  yogitapatel1920@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr MayurA Pawaskar 
Designation  Professor 
Affiliation  Dr. DY Patil Deemed to be University 
Address  Dr.DY Patil School of Ayurveda, Nerul , Navi Mumbai Department Of Shalya Tantra School Of Ayurveda, DY Patil Deemed to be University,Navi Mumbai
Dr.DY Patil School of Ayurveda, Nerul , Navi Mumbai Department Of Shalya Tantra School Of Ayurveda, DY Patil Deemed to be University,Navi Mumbai
Thane
MAHARASHTRA
400706
India 
Phone  9004215670  
Fax    
Email  mayur.pawaskar@dypatil.edu  
 
Details of Contact Person
Public Query  
Name  Dr MayurA Pawaskar 
Designation  Professor 
Affiliation  Dr. DY Patil Deemed to be University 
Address  Dr.DY Patil School of Ayurveda, Nerul , Navi Mumbai Department Of Shalya Tantra School Of Ayurveda, DY Patil Deemed to be University,Navi Mumbai
Dr.DY Patil School of Ayurveda, Nerul , Navi Mumbai Department Of Shalya Tantra School Of Ayurveda, DY Patil Deemed to be University,Navi Mumbai
Thane
MAHARASHTRA
400706
India 
Phone  9004215670  
Fax    
Email  mayur.pawaskar@dypatil.edu  
 
Source of Monetary or Material Support  
Dr.DY Patil School of Ayurveda, Nerul , Navi Mumbai Department Of Shalya Tantra School Of Ayurveda, DY Patil Deemed to be University,Navi Mumbai 
 
Primary Sponsor  
Name  DrYogita Patel 
Address  Dr.DY Patil School of Ayurveda, Nerul , Navi Mumbai Department Of Shalya Tantra School Of Ayurveda, DY Patil Deemed to be University,Navi Mumbai 
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 
DrYogita Patel  DY PATIL Ayurvedic Hospital  OPD NO.3 Dr.DY Patil School of Ayurveda, Nerul , Navi Mumbai Department Of Shalya Tantra School Of Ayurveda, DY Patil Deemed to be University,Navi Mumbai
Thane
MAHARASHTRA 		 9158262055

yogitapatel1920@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K641||Second degree hemorrhoids. Ayurveda Condition: ARSAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-pratisAraNam, प्रतिसारणम् (Procedure Reference: Sushruta Samhita, Procedure details: The patient will be placed in the lithotomy position. Digital rectal examination and proctoscopy will be done to assess site, size and number of pile mass. The pile mass will be cleaned with normal saline and dry gauze piece .Kshar will be applied with the help of spatula till pile mass become pakva Jambu Phala color after tha,the pile mass will be washed with kanji and anal canal will be cleaned.)
2Comparator Arm (Non Ayurveda)-Rubber band ligation by Barron Pile Gun followed by Injection Polidicanol 3%dose - Injection Polidocanol 3% 2 to 3cc of foam in each pile mass
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  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).
 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
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 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
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 3 
Date of First Enrollment (India)   10/11/2023 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

 

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 ofpatikshareeyaksharon 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 ksharor 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 obtainkshar.

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)

 

 

 

 

 
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