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CTRI Number  CTRI/2023/07/055200 [Registered on: 13/07/2023] Trial Registered Prospectively
Last Modified On: 12/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Effect of ChandanBalaLakshadi Taila Guda Varti After lateral Internal Sphincterotomy in GudaParikartika ( Fissure - in- Ano) 
Scientific Title of Study   A Clinical Study to evaluate the efficacy of ChandanBalaLakshadi Taila Guda Varti After lateral Internal Sphincterotomy in GudaParikartika ( Fissure - in- Ano) 
Trial Acronym  nill 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR SANJAY GURJAR 
Designation  MS SCHOLAR 
Affiliation  Post Graduate Institute Of Ayurveda dsrrau Jodhpur 
Address  Room No 135 PG Department of Shalya Tantra Post Graduate Institute Of Ayurveda Dsrrau Jodhpur

Jodhpur
RAJASTHAN
342037
India 
Phone  8209200930  
Fax    
Email  snjyboad@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr Rajesh Kumar Gupta 
Designation  Professor and HOD of Shalya Tantra Department 
Affiliation  Post Graduate Institute Of Ayurveda dsrrau Jodhpur 
Address  Room No 135 PG Department of Shalya Tantra Post Graduate Institute Of Ayurveda Dsrrau Jodhpu

Jodhpur
RAJASTHAN
342037
India 
Phone  9636520573  
Fax    
Email  guptadrrajeshkumargupta@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prof Dr Rajesh Kumar Gupta 
Designation  Professor and HOD of Shalya Tantra Department 
Affiliation  Post Graduate Institute Of Ayurveda dsrrau Jodhpur 
Address  Room No 135 PG Department of Shalya Tantra Post Graduate Institute Of Ayurveda Dsrrau Jodhpu


RAJASTHAN
342037
India 
Phone  9636520573  
Fax    
Email  guptadrrajeshkumargupta@gmail.com  
 
Source of Monetary or Material Support  
OPd No 14 PG Dept of Shalya Tantra Sanjeevni hospital DSRRAU Jodhpur Rajastha 
 
Primary Sponsor  
Name  Post Graduate Institute of Ayurved Jodhpur 
Address  Post Graduate Institute of Ayurved Joshpur Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur Rajasthan 
Type of Sponsor  Government funding agency 
 
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 
Prof Dr Rajesh Kumar Gupta  Sanjeevni Hospital DSRRAU Jodhpur  OPd No 14 PG Dept of Shalya Tantra Sanjeevni Hospital DSRRAU Jodhpur Rajasthan
Jodhpur
RAJASTHAN 		 9636520573

guptadrrajeshkumargupta@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE PGIA JODHPUR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K602||Anal fissure, unspecified. Ayurveda Condition: PARIKARTIKA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: ChandanBalaLakshadiTaila , Reference: yogratnakar sarav jwarvinashnam 1-8, Route: Rectal, Dosage Form: Varti/ Suppository, Dose: 5(ml), Frequency: od, Bhaishajya Kal: Sabhakta, Duration: 1 Weeks, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1 Patient who will give written consent.
2 Patient should be in 10 to 80 age group.
3 Patient with classical signs & symptoms of GudaParikartika. 
 
ExclusionCriteria 
Details  ● Patient suffering from AIDS and Hepatitis B.
● Patient related with any malignancy of Anorectal Region.
● Patient suffering from uncontrolled diabetes and Tuberculosis. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To know the efficacy of Chandalbalalakshadi taila guda varti for post operative pain in guda
parikartika. 		 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To know the efficacy of guda varti of chandanbalalakshadi taila for management of anal
pain after lateral internal sphincterotomy. 		 4 weeks 
 
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)   24/07/2023 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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   Ayurveda is the science of life which deals with the mental and physical health of a person. Aim of ayurvedais not only to cure disease but also to keep and maintain one’s health. In ancient time and today also ayurveda is followed in every family as home remedy as ritual, in diet form etc. But in the modern era, everyone is busy in their career and has a hurry-buried lifestyle. All became career & money conscious but ignored health. Other than this, everyone is attracted to luxurious life and has competition with others life standards. So, we adopted modernization, fast food, outdoor foods, irregular routine of sleep and diet, which directly indirectly increases the stress level and disturbs sleep. And we all know that our sleep is directly related to our stomach/digestion. All these factors disturb this digestion cycle and lead to constipation or diarrhoea, which further leads to the anorectal and digestion related problems. Fissure is the most common anorectal disease and the common problem associated with this digestive cycle. The description of this condition is described in the ancient treatises as a complication of Virechanaor Basti therapies which goes by the name of "GudaParikartika". Acharya Sushruta described the symptoms of the fissure as cutting or burning pain in anus, penis, umbilical region and neck of urinary bladder with cessation of flatus. 
●                                                     à¤•à¥à¤·à¤¾à¤®à¥‡à¤£à¤¾à¤¤à¤¤à¤¿à¤‚मृदुकोष्ठेन मन्दाति रुक्षेण वाऽतततीक्ष्णोष्णाततलवणमततरुक्ष वा पीतमौषध तपत्तातनलौ प्रदूष्य 
                                                          पररकततिकामापादयतत तत्र गुदनातभमेढवस्तितिरः सुसदाहिं पररकतिनमतनलसिंगो वायुतवष्टम्मो भक्तारुति भवततl(सु.चि.34/16) 

According to modern science fissure in ano is the longitudinal or oval shaped tear wound in the anal canal, below the dentate line extending to anal verge. It may be acute or chronic symptoms include cutting pain, bleeding with defecation and spasticity of anal sphincters. It may be present with a sentinel tag. The most common site for males and females is the posterior midline, greater than 75% occur in this location. Approximately 25% of fissures are in the anterior location and these are more common in women. Less than 1% of all fissures are located off the midline position and these are considered atypical fissures. Fissure may be due to associated with Crohn’s disease, ulcerative colitis, anal cancer, tuberculosis, HIV, syphilis.

MATERIAL AND METHOD: SOURCE OF DATA: Patients with classical sign and symptoms ofGudaParikartika will be selected and registered from OPD and IPD of University College of Ayurveda Hospital, Dr.Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur; irrespective of age, sex, religion, occupation etc., full filing the criteria of selection and eligible for the study. Patients may be hospitalized as per the requirement and condition of the patient. SAMPLE SIZE: 30 patients suffering from GudaParikartika will be selected based on simple random sampling. INFORMED CONSENT: Written informed consent will be taken from each patient before starting the study. 
SELECTION OF PATIENTS:
 INCLUSION CRITERIA:
 â— Patient who will give written consent.
 â— Patient should be in 10 to 80 age group. 
● Patient with classical signs & symptoms of GudaParikartika.
 EXCLUSION CRITERIA: 
● Patient suffering from AIDS and Hepatitis B.
 â— Patient related with any malignancy of Anorectal Region. 
● Patient suffering from uncontrolled diabetes and Tuberculosis. 
WITHDRAWAL CRITERIA: 
● Patients which may be found hypersensitive with the selected management will be discarded from the study even after registration. 
● If any serious condition or adverse effect appears during the treatment which requires urgent treatment. 
● If a patient wants to withdraw oneself from the clinical study. INVESTIGATION: 
● CBC ï‚· ESR ï‚· Blood sugar ï‚· BT ï‚· CT ï‚· Biopsy (as per need) ï‚· HIV ● HbsAg ● VDRL ● PERRECTAL EXAM. 

 
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