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CTRI Number  CTRI/2022/05/042647 [Registered on: 19/05/2022] Trial Registered Prospectively
Last Modified On: 04/05/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Surgical/Anesthesia
Preventive 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   “MANAGEMENT OF PILES(2ND DEGREE) BY USING KSHARA (AYURVEDIC INTERVENTION) AND SCLEROTHERAPY”  
Scientific Title of Study   “MANAGEMENT OF ARSHA (2ND DEGREE INTERNAL HEMORRHOIDS) BY USING APAMARGA PRATISARANEEYA KSHARA AND SCLEROTHERAPY: A RANDOMISED COMPARATIVE CLINICAL TRIAL”  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Deepak khundia  
Designation  PG Scholar  
Affiliation  All India Institute of Ayurveda  
Address  Room no. 506 Dept of shalya tantra 5th floor Academic block All india institute of ayurveda Sarita vihar gautampuri 110076

South West
DELHI
110076
India 
Phone  7404311012  
Fax    
Email  deepakkhundia340@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vyasdeva Mahanta 
Designation  Associate Professor  
Affiliation  All India Institute of Ayurveda  
Address  Room no. 506 Dept of shalya tantra 5th floor Academic block All india institute of ayurveda Sarita vihar gautampuri 110076

South
DELHI
110076
India 
Phone  7404311012  
Fax    
Email  drvyasayu@yahoo.in  
 
Details of Contact Person
Public Query  
Name  Dr Deepak khundia  
Designation  PG Scholar  
Affiliation  All India Institute of Ayurveda  
Address  Room no. 506 Dept of shalya tantra 5th floor Academic block All india institute of ayurveda Sarita vihar gautampuri 110076


DELHI
110076
India 
Phone  7404311012  
Fax    
Email  deepakkhundia340@gmail.com  
 
Source of Monetary or Material Support  
All india institute of ayurveda  
 
Primary Sponsor  
Name  All india institute of Ayurveda  
Address  All india institute of ayurveda Sarita vihar gautampuri 110076 
Type of Sponsor  Research institution and hospital 
 
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 
Deepak Khundia  All India institute of Ayurveda, sarita vihar, New Delhi, 110076  All India institute of Ayurveda, sarita vihar, New Delhi, 110076
South
DELHI 		 7404311012

deepakkhundia340@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
1Comparator Arm (Non Ayurveda)-sclerotherapyInj.Polidacanol (Sclerosant) 2-3 ml, 3% in base of each pile mass (1 ml = 30 mg).Single sitting, if needed another sitting will be done after 7 days
2Comparator ArmProcedure-pratisAraNIya-kShAraH (Procedure Reference: sushruta samhita sutrasthan 11, Procedure details: In sufficient quantity, Teekshna Apamarg Kshara will be applied over single pile mass For 100 Matra Kala (Single sitting, if needed another sitting will be done & observed after 7 days).)
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1) Patients of age between 20 - 60 years age group.
2) Patients presenting with signs and symptoms of 2
nd degree internal Hemorrhoids.
- Prolapse that goes back in on its own
- Pain less bleeding
3) Patient willing for Kshara therapy / Sclerotherapy. 
 
ExclusionCriteria 
Details  1) Patients with 3
rd or 4
th degree internal haemorrhoids and Bahya Arsha
(ExternalPiles).
2) Patients contraindicated for Kshara Karma.
3) Infective / Inflamed / Thrombosed Piles.
4) Arsha associated with one or more of the following problems:
Ano-rectal & other malignancy
Fissure and fistula-in-ano
Rectal prolapse
Uncontrolled Hypertention
Diabetes mellitus
Acute/chronic ulcerative colitis
Crohn’s disease
H/o Tuberculosis
HIV, HBsAg & VDRL Positive cases
Other metabolic disorders
Pregnancy
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1) Reduction in size of pile mass and stoppage of bleeding.
2) To record the effectiveness in sign & symptoms of piles after application of
Teekshna Apamarga Kshara application and Sclerotherapy.
 		 1) Reduction in size of pile mass and stoppage of bleeding in 4 weeks.
2) the effectiveness in sign & symptoms of piles after application of
Teekshna Apamarga Kshara application and Sclerotherapy in 4 weeks.
 
 
Secondary Outcome  
Outcome  TimePoints 
1) Comparative outcome of Apamarga Pratisarneeya Kshara and Sclerotherapy
2)Improvement in quality of life. 		 1) Comparative outcome of Apamarga Pratisarneeya Kshara and Sclerotherapy in 5 weeks
2)Improvement in quality of life in 5 weeks. 
 
Target Sample Size   Total Sample Size="37"
Sample Size from India="37" 
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)   16/06/2022 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nill 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   INTRODUCTION : 
Sushruta has mentioned four folds therapeutic procedure in the management of Arsha, namely Bheshaja karma (medicinal treatment), Kshara karma (use of caustics), Agnikarma (use of heat) and Shastra karma (surgery).i Kshara is a caustic material, alkaline in nature obtained from the ashes of medicinal plants. It is a milder procedure compared to Shastra Karma (Surgery) and Agnikarma (Thermal cautery). Kshara is described as one among the Anu-shastra or Upayantras. It is said to be superior among all the sharp and subsidiary instruments by virtue of its Chedana (Excision), Bhedana (incision), Lekhana (scraping) as well as Tridoshaghna properties. Kshara Karma is indicated in Arsha Chikitsa and use of Apamarga Kshara is mentioned by Chakradutta (Arsha Chi.10) iii. Preparation of Kshara is thoroughly described in Sushruta Sutra Sthan.
NEED OF STUDY  : 
The present study is an attempt for the fulfilment of the above need with Pratisaraneeya Kshara application, prepared from the plant of Apamarga (Achyranthus aspera). It consists a Comparative clinical evaluation of Pratisaraneeya Kshara application with Sclerotherapy as a control group in management of 2nd Degree Hemorrhoid
SAMPLE SIZE :
Assuming 95% confidence level 80º two-sided test calculated sample size is 33. With the assumption of 10% dropout, we will take 37 patients per groups.
INCLUSION CRITERIA 1) Patients of age between 20 - 60 years age group. 2) Patients presenting with signs and symptoms of 2 nd degree internal Hemorrhoids. - Prolapse that goes back in on its own - Pain less bleeding 3) Patient willing for Kshara therapy / Sclerotherapy
EXCLUSION CRITERIA: 1) Patients with 3 rd or 4 th degree internal haemorrhoids and Bahya Arsha (ExternalPiles). 2) Patients contraindicated for Kshara Karma. 3) Infective / Inflamed / Thrombosed Piles. 

 
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