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CTRI Number  CTRI/2016/02/006679 [Registered on: 25/02/2016] Trial Registered Retrospectively
Last Modified On: 06/11/2015
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Clinical trial in Chronic fissure in ano 
Scientific Title of Study   A Comparative Clinical study of Ksharasootra Application and Lateral Internal Sphincterotomy in the Management of Parikartika (Chronic Fissure-in-Ano) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Manoj Bhadja 
Designation  M S Ayu Shalya Tantra 
Affiliation  IPGT RA 
Address  OPD No 1 Department of shalya tantra IPGT and RA Hospital Gujarat Ayurveda University Jammagar
OPD No 1 Department of shalya tantra IPGT and RA HOSPITAL GAU Jammagar
Jamnagar
GUJARAT
361008
India 
Phone  09727871722  
Fax    
Email  bhadjamanoj@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR T S DUDHAMAL 
Designation  assistant professor 
Affiliation  IPGT RA 
Address  OPD No 1 Department of shalya tantra IPGT and RA HOSPITAL GAU Jammagar
OPD No 1 Department of shalya tantra IPGT and RA HOSPITAL GAU Jammagar
Jamnagar
GUJARAT
361008
India 
Phone  09428671939  
Fax    
Email  drtsdudhamal@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR S K GUPTA 
Designation  PROF HOD 
Affiliation  IPGT RA 
Address  OPD No 1 Department of shalya tantra IPGT and RA HOSPITAL GAU Jammagar
OPD No 1 Department of shalya tantra IPGT and RA HOSPITAL GAU Jammagar
Jamnagar
GUJARAT
361008
India 
Phone  09428317639  
Fax    
Email  drskgupta17@gmail.com  
 
Source of Monetary or Material Support  
IPGT RA GAU Jamnagar Gujarat India 
 
Primary Sponsor  
Name  IPGT RA GAU Jamnagar Gujarat India 
Address  IPGT RA GAU Jamnagar Gujarat India 361008 
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 
Manoj Bhadja  IPGT RA Hopsitaal Gujarat Ayurved University Jamnagar  OPD No 1 Department of Shalya Tantra IPGT RA hospital Gujarat Ayurved University Jamnagar
Jamnagar
GUJARAT 		 09727871722

bhadjamanoj@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  PARIKARTIKA FISSURE IN ANO,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Apamarg Ksharasootra application with transfixation of sentinel tag  Apamarg Ksharasootra application with transfixation of sentinel tag will be done once under local anesthesia in operation theater. After cut through of Ksharasootra wound dressing will be done up to four weeks or till wound healing which is earlier. 
Comparator Agent  Lateral internal sphincterotomy followed by excision of sentinel tag  Lateral internal sphincterotomy followed by excision of sentinel tag will be done once under local anesthesia in operation theater. Wound dressing will be done up to four weeks or till wound healing which is earlier. 
 
Inclusion Criteria  
Age From  17.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients of Parikartika Chronic fissure in ano having duration more than 6 months 
 
ExclusionCriteria 
Details  1 Fissure in ano having duration less than 6 months
2 Patient suffering from malignancy
3 Patient suffering from HIV VDRL HepatitisB TB
4 Chronic fissure in ano associated with piles and fistula
5 Uncontrolled cases of Diabetes Mellitus and Hypertension
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Assessment will be done on the basis of specially prepared Performa for assessing relief in sign and symptoms by scoring pattern  1 month 
 
Secondary Outcome  
Outcome  TimePoints 
Assessment will be done on the basis of specially prepared Performa for assessing relief in sign and symptoms by scoring pattern  1 month 
 
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 1/ Phase 2 
Date of First Enrollment (India)   02/03/2015 
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)  Open to Recruitment 
Publication Details   not yet publised 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This study is open label comparative clinical study of ksharsootra application and lateral internal sphincterotomy in the management of parikartika (fissure in ano).
Routine blood investigation will be performed to rule out other
systematic pathology.
Special scoring scale has been prepared based on information in
Ayurvedic classical texts which will be utilized for assessment and evaluation

MATERIALS & METHODS:

·         Selection of patient:

1.      Patients of Parikartika (Chronic fissure-in-ano) will be selected from OPD /IPD of Shalya Tantra, I.P.G.P.T. &R.A. Hospital, Jamnagar, irrespective of gender, occupation, religion, etc.

2.      The patient will be registered and randomly divided into two groups.

3.      The patients shall also be collected from the special camps organized outside the city & they would be admitted in I.P.G.T. & R.A. Hospital, Jamnagar.

METHOD:

·         Grouping of Patients :

The patients shall be randomly divided into two groups A & B, having 15 patients in each group.

Group-A:  Apamarg Ksharasootra application with transfixation of sentinel tag.     

Group-B:  Lateral internal sphincterotomy followed by excision of sentinel tag.

 Management:

·         Pre-Operative (Common for both groups):

1.    Fitness of patient

2.    Evacuation of bowel with soap water enema.

3.   Local Anesthesia

4.    CONSENT- written informed consent will be taken.

 

·         Operative Procedure

Group-A

  1. Patient laid in lithotomy position, painting & draping will be done.
  2. Procedure will be carried out under local anesthesia (Inj. Xylocaine 2% with adrenaline).
  3. Ligation of sentinel tag will be done with Apamarga Ksharasootra after maximum possible dilatation.
  4. The operation will be carried out in OT and under aseptic precautions.
    1. Group-B
    1. Patient laid in lithotomy position, painting & draping will be done.
    2. Procedure will be carried out under local anesthesia (Inj. Xylocaine 2% with adrenaline).
    3. Lateral internal sphincterotomy followed by excision of fissure with sentinel tag will done.
    4. The operation will be carried out in OT and under aseptic precautions.

     

    ·         Post-Operative(Common for both groups):

    1. Warm water sitz bath along with panchwalkal kwath, two times a day.
    2. Erandbhrishta Haritaki churna- 5 gm at bed time with luke warm water daily.
    3. Matra Basti with Jatyadi Tail -10 ml, once daily after sitz bath.

     

    ·         Duration of treatment:

    Single sitting operation and adjuvant therapy up to complete wound healing or maximum four weeks.

     

    ·         Follow-up Period: One month   

     

    ·         Laboratory Investigation:

    a.     CBC

    b.     FBS, PPBS.

    c.     Blood urea, Sr. Creatinine, Sr. Billirubin if required

    e.     HIV, VDRL, HBsAg

                     f.     Urine analysis- Routine & Microscopic

     

     

    ·         Other Investigation:

    a.     Chest X-Ray – if required for fitness.

    b.     ECG – if required for fitness.

    c.     USG Abdomen & Pelvis – if required.

         d.    Colonoscopy – if required.

     ASSESSMENT CRITERIA:

    Assessment will be done on the basis of specially prepared Performa for assessing relief in sign & symptoms by scoring pattern.

 
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