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CTRI Number  CTRI/2019/07/020369 [Registered on: 25/07/2019] Trial Registered Prospectively
Last Modified On: 24/07/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Application of Kshara in Internal Haemorrhoids. 
Scientific Title of Study   A COMPARATIVE CLINICAL STUDY OF VASA PRATISARANEEYA TEEKSHNA KSHARA AND APAMARGA PRATISARANEEYA TEEKSHNA KSHARA IN THE MANAGEMENT OF ABHYANTARA ARSHA (INTERNAL PILES) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  ProfPHKumar 
Designation  Professor and Head of the Department 
Affiliation  national institute of ayurveda 
Address  National Institute of Ayurveda PG Department of Shalya Tantra department National Institute of Ayurveda Jorawar Singh Gate , Madhav Villas Palace , Amer Road Jaipur Rajasthan 302002 India

Jaipur
RAJASTHAN
302002
India 
Phone  9414056362  
Fax    
Email  profphknia@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  ProfPHKumar 
Designation  Professor and Head of the Department 
Affiliation  national institute of ayurveda 
Address  National Institute of Ayurveda PG Department of Shalya Tantra National Institute of Ayurveda Jorawar Singh Gate , Madhav Villas Palace , Amer Road Jaipur Rajasthan 302002 India

Jaipur
RAJASTHAN
302002
India 
Phone  9414056362  
Fax    
Email  profphknia@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Prof P Hemantha Kumar 
Designation  Professor and Head of the Department 
Affiliation  national institute of ayurveda 
Address  NATIONAL INSTITUTE OF AYURVEDA JAIPUR RAJASTHAN MADHAV VILAS JAIPUR 302002

Jaipur
RAJASTHAN
302002
India 
Phone  9414056362  
Fax    
Email  profphknia@gmail.com  
 
Source of Monetary or Material Support  
none 
 
Primary Sponsor  
Name  National Institute of Ayurveda 
Address  Madhav Villas Palace, Amer Road Jaipur RAJASTHAN 302002  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India
Indonesia  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Himadri mudgal  National Institute of Ayurveda Hospital Jaipur Rajasthan  SHALYA TANTRA DEPARTMENT OPD NO-28
Jaipur
RAJASTHAN 
8279248738

drhimadrimudgal52@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC, NIA   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: K629||Disease of anus and rectum, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Apamarga pratisarneeya teekshna kshar   Application of Apamarga pratisarneeya teekshna kshar in abhyantra arsha in sufficient quantity for L/A application once and after 4 wk follow-up 
Intervention  vasa pratisarneeya teekshna kshar  Application of vasa pratisarneeya teekshna kshar in abhyantra arsha in sufficient quantity for L/A application once and after 4 wk follow-up 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients of Internal Arsha between the ages of 20 yrs to 65 yrs. ï‚· Patients of Internal Arsha which are Mridu, Prasrita, Avagada (Deep) and Uchchhrita (Projected). ï‚· Patients of Internal Arsha having Pittaja and Raktaja origin. ï‚· Diagnosed case of Internal Piles of First, second, third degree.  
 
ExclusionCriteria 
Details  Patients of Arsha, age less than 20 yrs. and more than 65 yrs. ï‚· Patients with other systemic illness like uncontrolled Diabetes mellitus, Hypertension, Malignancy, Hepatitis B, Tuberculosis and Retrovirus positive. ï‚· Grade IV Internal Piles. ï‚· External piles and other associated Ano-rectal diseases. ï‚· Infective and Neoplastic conditions of rectum, Rectal prolapse. ï‚· Pelvic pathology and Pregnancy.  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Patients of either sex of 20 to 65 years old diagnosed as Abhyantra arsha(Int. piles) will be selected for relief in sign and symptoms.
 
4 WEEK 
 
Secondary Outcome  
Outcome  TimePoints 
Recovery time. b. Time to return to work. c. Parental/patient satisfaction.   30 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 
Date of First Enrollment (India)   01/08/2019 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/08/2019 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   not published yet  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
Sushruta, the author of Sushruta Samhita, available text in Ayurveda surgical practice, has included Arsha in Ashta-Mahagada1.   The drastic change in lifestyle has caused rapid increase in the prevalence of this disease. The incidence rate of this disease is high among people with old age. At least fifty percent of the people over the age fifty years have some degree of symptoms related to piles2. In Sushruta Samhita, the treatment modality for Arsha has been divided into four categories3 i.e. Bheshaja Chikitsa (Medical treatment), Kshara Karma (Caustic Therapy), Agnikarma (Thermal cautery Therapy) and Shastra Karma (Surgery). Kshara Karma is indicated in Arsha which are Mridu, Prasrita, Avagada and Uchchhrita4. Sushruta explained two types of Kshara in treatment of Arsha i.e. Paneeya and Pratisaraneeya5. Sushruta has mentioned twenty six drugs for the preparation of Pratisaraneeya Kshara6. Among them I have selected Vasa Pratisaraneeya Teekshna Kshara in the management of Abhyantara Arsha (Internal piles).                  I.  AIM  To evaluate and compare the efficacy of Vasa Pratisaraneeya  Teekshna Kshara  and  Apamarga Pratisaraneeya Teekshna Kshara  in the management of  Abhyantara Arsha.  
 
II. OBJECTIVES                                                                                                                                                   1. To evaluate the effect of Vasa Pratisaraneeya Teekshna Kshara in the management of Abhyantara Arsha.  2. To compare the effect of Vasa Pratisaraneeya Teekshna Kshara and Apamarga Pratisaraneeya Teeskhna Kshara in the management of  Abhyantara Arsha.  3. To study the prepared Vasa Pratisaraneeya Teekshna Kshara phytochemically. 
 Arms  Assigned  Intervention Group A - 15 Patients withI0, II0& III0 Abhyantara Arsha. Apamarga Pratisaraneeya   Teekshna Kshara Control group Procedure: Apamarga Pratisaraneeya Teekhshna Kshara application. The procedure will be done under L.A/S.A. The Kshara will be applied on individual Int. Pile mass for until it turns Pakwa Jambuphala Varna and then it will be washed with Nimbu Swarasa. Group B - 15 Patients with I0, II0&III0Abhyantara Arsha. Vasa Pratisaraneeya Teekshna Kshara Trial group Procedure: Vasa Pratisaraneeya Teekshna Kshara application. The procedure will be done under L.A/S.A. The Kshara will be applied on individual Int. Pile mass until it turns Pakwa Jambuphala Varna and then it will be washed with Nimbu Swarasa.                                                                                                                       Post-Operative Treatment 
1.  Triphala Guggulu 500 mg. twice daily after meal for 7 days  
2. Laxative- Haritaki Choorna 5 gm. at bed time for 7 days with luke warm water.  
3. Warm Sitz bath by Tankan Bhasma 1/2 tsf - twice daily for 7 days 
4. Yasthimadhu Taila Matra Basti 15 ml. twice daily for 7 days.  
5. Yasthimadhu Taila for P/R Pichu twice daily for 7 days                                                                                                                                                                                                                                                Method of Preparation of Apamarga / Vasa Pratisaraneeya Teekshna Kshara15:            The Panchanga of Apamarga / Vasa plant will be collected, dried up and burnt. Then this ash will be collected and mixed with six times of water and filtered 21 times. When the filtrate shall be clean and clear like Gomutra Varna and it will be kept on mild fire and reduced to 2/3rd. Then red hot Shukti (weight 1/10th part of ash) shall be added into the filtrate solution and will be continuously stirred well until it shall reduce to 1/3rd. This shall be further heated up by adding Chitraka Kalka (weight 1/10th part of Shukti). Thick solution will be obtained and this is known as Apamarga /Vasa Pratisaraneeya Teekshna Kshara. It will be collected and stored in air tight container.                                                                                                                                         Procedure of Kshara application : 
  The patient will be placed in lithotomy position on operation table and the perianal area will be cleaned with aseptic solutions. Then draping will be done with sterilized cut sheet. After then local infiltration anesthesia will be given. With the help of Ghrita smeared Arshoyantra, pile masses will be re-assessed for their numbers, positions and sizes. One pile mass at a time will be selected. The pile mass will be scraped or rubbed and cleaned with cotton swab soaked with warm water. Then the Vasa or Apamarga Kshara will be applied over the pile mass with the help of Darvimukha Shalaka under direct vision. As soon as applying the Kshara, the opening of the Arsho Yantra will be closed by cotton swab and wait for a period of hundred Matra Kala. When the colour of pile mass is looked like Pakwa Jambhuphala, the extra Kshara will be washed out with freshly prepared Nimbu Swarasa. Later the anal packing will be done with Yashtimadhu Taila Pichu. All the pile masses will be applied in a single sitting. 
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 ASSESSMENT CRITERIA   
A.  Subjective Parameters:  a. Ruja  (Post operative pain)  b. Raktashrava (Bleeding)  
B.  Objective Parameter:  
a.    Size of the pile mass. b. Colour of pile mass. c. Anal sphincter tonicity (by Hemantha Kumar Modified Sphincterometer) 
 
C.  Secondary Outcome Measures   a. Recovery time.  b. Time to return to work.   c. Parental/patient satisfaction.    
 
 
 
  
 
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