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CTRI Number  CTRI/2017/04/008377 [Registered on: 20/04/2017] Trial Registered Retrospectively
Last Modified On: 18/04/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Ayurvedic treatment of piles 
Scientific Title of Study   A comparative study of Kadali Pratisaraneeya kshara and Apamarga Pratisaraneeya Kshara in the management of Internal Haemorrhoids 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Hardik 
Designation  PG scholar 
Affiliation  Gujarat ayurved university 
Address  Department of Shalya tantra opd no. 116, Parul Ayurveda hospital, P.O. Limda, Ta. Waghodia, Dist- Vadodara- 391760

Vadodara
GUJARAT
391760
India 
Phone  9033011658  
Fax    
Email  hardikvariya9@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr D S Dave 
Designation  Professor 
Affiliation  Gujarat ayurved university 
Address  Department of Shalya tantra opd no. 116, Parul Ayurveda hospital, P.O. Limda, Ta. Waghodia, Dist- Vadodara- 391760

Vadodara
GUJARAT
391760
India 
Phone  9033011658  
Fax    
Email  drdsdave1954@gmail.com  
 
Details of Contact Person
Public Query  
Name  Hardik 
Designation  PG scholar 
Affiliation  Gujarat ayurved university 
Address  Department of Shalya tantra opd no. 116, Parul Ayurveda hospital, P.O. Limda, Ta. Waghodia, Dist- Vadodara- 391760

Vadodara
GUJARAT
391760
India 
Phone  9033011658  
Fax    
Email  hardikvariya9@gmail.com  
 
Source of Monetary or Material Support  
Department of Shalya Tantra, opd no 116 parul ayurveda hospital limda Vadodara-391760 
 
Primary Sponsor  
Name  Parul Institute of Ayurved 
Address  Parul institute of Ayurved, P.O. Limda, Ta. Waghodia, Dist- Vadodara 
Type of Sponsor  Private medical college 
 
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 
Hardik variya  Parul Ayurved Hospital  Parul Ayurved Hospital, IPD and OPD shalya tantra department. P.O. Limda, Ta. Waghodia, Dist- Vadodara
Vadodara
GUJARAT 		 9033011658

hardikvariya9@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PIA-IECHR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Complication of Piles (Internal Haemorrhoids),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Apamarga Pratisaraneeya Kshara  2gm Kshara apply on internal Pile and only 1 sitting 
Intervention  Kadali Pratisaraneeya Kshara   2gm Kshara apply on internal Pile and only 1 sitting 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  The Abhyantara Arshas of 2nd degree and 3rd degree which are soft, broad, deep and bulged up.
Patients group of age 16 to 60 years. 
 
ExclusionCriteria 
Details  Pregnancy.
Tuberculosis.
Diabetes mellites.
HIV infection.


 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Changes in VAS  1 month 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in gradation of subjective and objective parameters.  1 month 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   01/02/2016 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   No 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary    In the past years the pattern of the disease heamorrhoids has changed with the arrival of the modern procedures. These procedures are universally acceptable but recurrence rate is high, modern science has very little to offer in terms of medical treatments of heamorrhoids. This Study was planned to evaluate the efficacy of Kadali Pratisaraneeya Kshara as trial group and standard group being Apamarga Pratisaraneeya Kshara on Internal Haemorrhoids., which are soft, broad, deep & bulged up. This modality incorporates the topical application of Kshara on internal piles. Kshara karma is one of the para-surgical modality utilised in the management of piles. Kadali and Apamarga plants chemical substance and its corrosive nature. When applying kshara on a piles its corrosive nature piles burn and slough out and patient cure and describing in below in chemical composition how to work.

The wood ashes contain potassium and sodium carbonates (K2CO3 and Na2CO3). Limestone and seashells contain calcium carbonates (CaCO3). On heating strongly carbonate decomposes into calcium oxide (CaO), quick lime and carbon dioxide (CO2), which escapes into the air. Calcium oxide reacts with water vigorously and gives calcium hydroxide (CaOH), which is limewater indeed. Calcium hydroxide reacts with potassium/ sodium carbonate and gives rise to calcium carbonate, which comes down as precipitate. Alkali hydroxide (KOH) remains in solution, which may be concentrated by boiling to different extents. This essential chemical reaction can be expressed in terms of the following equations.

1.      CaCO3 à CaO + CO2

2.      CaO + H2O à Ca(OH)2

3.      K2CO3 + Ca(OH)2 à 2KOH + CaCO3

 
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