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CTRI Number  CTRI/2024/07/071193 [Registered on: 24/07/2024] Trial Registered Prospectively
Last Modified On: 24/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Chitrak pratisarniya kshar and guggulu coated chitrak kshar sutra in 2nd degree hemorrhpids 
Scientific Title of Study   Clinical comparative study to evaluate the efficacy of application of chitrak pratisarniya kshar and ligation with guggulu coated chitrak kshar sutra in the management of 2nd degree internal hemorrhoids. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Grishma Rakholiya 
Designation  MS Scholar 
Affiliation  Post Graduate Institute Of Ayurved Jodhpur,Rajasthan 
Address  P.G. Department Of shalya tantra, Post Graduate Institute of Ayurved ,Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur Rajasthan Jodhpur RAJASTHAN 342037 India

Jodhpur
RAJASTHAN
342037
India 
Phone  8238083200  
Fax    
Email  grakholiya162@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Grishma Rakholiya 
Designation  MS Scholar 
Affiliation  Post Graduate Institute Of Ayurved Jodhpur,Rajasthan 
Address  P.G. Department Of shalya tantra, Post Graduate Institute of Ayurved ,Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur Rajasthan Jodhpur RAJASTHAN 342037 India


RAJASTHAN
342037
India 
Phone  8238083200  
Fax    
Email  grakholiya162@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prof Dr Rajesh Kumar Gupta 
Designation  Professor & head of Department 
Affiliation  Post Graduate Institute Of Ayurved Jodhpur,Rajasthan 
Address  P.G. Department of Shalya Tantra, Post Graduate Institute Ayurved ,Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur Rajasthan Jodhpur RAJASTHAN 342037 India

Jodhpur
RAJASTHAN
342037
India 
Phone  9636520573  
Fax    
Email  guptadrrajeshkumargupta@gmail.com  
 
Source of Monetary or Material Support  
Post Graduate Institute of Ayurved Jodhpur Rajasthan india 342037 
 
Primary Sponsor  
Name  Post Graduate Institute of Ayurved Jodhpur Rajasthan 
Address  P.G. Department of Shalya Tantra, Post Graduate Institute Ayurved ,Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur Rajasthan 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Grishma Rakholiya  Post Graduate Institue of Ayurved,Jodhpur,Rajasthan  P.G. Department of Shalya Tantra, Post Graduate Institute Ayurved ,Dr. Sarvepalli Radhakrishnan Ayurved University, Jodhpur Rajasthan. Jodhpur RAJASTHAN
Jodhpur
RAJASTHAN 		 8238083200

grakholiya162@gmail.com 
Dr Grishma Rakholiya  sanjivni hospital,post graduate institute of ayurveda  P.G. Department Of shalya tantra, Post Graduate Institute of Ayurved ,Dr. Sarvepalli Radhakrishnan Ayurved University, Jodhpur Rajasthan Jodhpur RAJASTHAN 342037 India
Jodhpur
RAJASTHAN 		 8238083200

grakholiya162@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Post Graduate Institute of Ayurved,Jodhpur  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: ARDRA-ARSAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-kShArakarma, क्षारकर्म (Procedure Reference: Sushruta chikitsa 6, Procedure details: Anus is lubricated with ghee then the proctoscope also smeared with ghee is pushed into the anus slowly & straight when the patient is bearing down. After it has entered the pile mass is observed raised by a rod like instrument massaged with cotton swab then chitrak kshar placed on it after applying the kshar the mouth of proctoscope is kept closed by the h& for a period of one hundred matra afterwards the pile mass is kneaded with clothe & then considering the strength of caustic alkali & the disease it is applied once again. When the pile mass appears like a ripe fruit of jambu dull then it cleaned with nimbu swarasa then proctoscope taken out. Same procedure is done in other pile mass one by one.)
(1) Medicine Name: Chitrak pratisarneeya kshara, Reference: Sushruta Sutra 11, Route: Rectal, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: od, Duration: 1 Days
2Comparator ArmProcedure-kShArasUtra, क्षारसूत्र (Procedure Reference: Chakradutt arshchikitsa prakrarna 5, Procedure details: Anus is lubricated with ghee then the pile mass is observed & base of the pile mass is clamped by pile holding forcep then after at the base of 2nd degree hemorrhoids is transfixed & ligated with guggulu coated chitrak kshar sutra after that above ligation of pile mass is crushed by forceps then after pile holding forcep is remove.)
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patient presenting with complain of 2
nd degree Arsh i.e.
1. Bleeding per rectum
2. Prolapse of pile
3. Pain
4. Discharge and pruritus
5. Age group 18-60 years 
 
ExclusionCriteria 
Details  Patient with other systemic illness like
1. Uncontrolled Diabetes mellitus
2. Hypertension
3. Malignancy
4. Hepatitis B
5. Tuberculosis
6. Pregnant women
7. Third and Fourth degree internal piles, external piles and other associated anorectal diseases.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To check and compare the complete removal of 2nd degree internal hemorrhoids and better healing by application of chitrak pratisarneeya kshar and ligation with guggulu coated chitrak kshara sutra in two different groups   60 days 
 
Secondary Outcome  
Outcome  TimePoints 
To improve general health of patient.
 		 60 days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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/ Phase 4 
Date of First Enrollment (India)   20/08/2024 
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="0"
Months="2"
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   Number of patients - 40
Type of Study - Open Labelled
 Procedure - group A- ksharkarma-application of chitrak pratisarniya kshar in 2nd degree internal hemorrhoids.
                     group B-ksharsutra-ligation with guggulu coated chitrak kshar sutra in 2nd degree internal hemoerrhoids.
Randomization - Simple
 Duration of study - 60 Days with weekly Follow up 
 
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