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CTRI Number  CTRI/2017/10/009963 [Registered on: 03/10/2017] Trial Registered Retrospectively
Last Modified On: 25/02/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To Know the most effective treatment in between medicated thread of Apamarg and lateral cut inside to the sphincter in Chronic Fissure in Ano 
Scientific Title of Study   A comparative clinical study of Apamarg Ksharasootra and Lateral Internal Sphincterotomy in the management of Parikartika (Chronic Fissure-In-Ano)-A open randomized Trial  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Gajiram Dharamdas Banothe 
Designation  PhD Scholar 
Affiliation  Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar 
Address  Department of Shalyatantra IPGT and RA Gujarat Ayurved University Jamnagar

Jamnagar
GUJARAT
361008
India 
Phone  7046243508  
Fax    
Email  amanbanothe@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr T S Dudhamal 
Designation  Associate Professor 
Affiliation  Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar 
Address  Department of Shalyatantra I P G T and R A GAU Jamnagar
Department of Shalyatantra I P G T and R A GAU Jamnagar
Jamnagar
GUJARAT
361008
India 
Phone  9428671939  
Fax    
Email  drtsdudhamal@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Gajiram Dharamdas Banothe 
Designation  PhD Scholar 
Affiliation  Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar 
Address  Department of Shalyatantra IPGT and RA GAU Jamnagar

Jamnagar
GUJARAT
361008
India 
Phone  7046243508  
Fax    
Email  amanbanothe@gmail.com  
 
Source of Monetary or Material Support  
Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar Gujarat 
 
Primary Sponsor  
Name  Not Any 
Address  Not Any 
Type of Sponsor  Other [] 
 
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 
Gajiram Banothe  Institute for Post Graduate Teaching and Research in Ayurveda   Room no 630 6th floor Department of Shalya Tantra IPGT and RA
Jamnagar
GUJARAT 
7046243508

amanbanothe@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  Fissure in Ano,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Apamarga Ksharasootra  medicated thread prepared by 13 coating of snuhi kshira followed by 5 coatings of snuhi plus apamarga ksharafollowed by 3 coatings of haridra 
Comparator Agent  lateral internal sphincterotomy  a surgical method used to incise internal sphincter 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients of Parikartika (Chronic fissure-in-ano) having duration more than 6 months.
Age group between 18-60 years.
 
 
ExclusionCriteria 
Details  1) Fissure-in-ano having duration- less than 6 months.
2) Chronic fissure-in-ano associated with piles & fistula.
3) Patient below 18 & above 60 years of age
4) Patient suffering from HIV, VDRL, HepatitisB, T.B.
5) Uncontrolled cases of Diabetes Mellitus and Hypertension.
6) Patient suffering from malignancy.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Apamarga Ksharasootra is more effective than lateral internal sphincterotomy  1 month 
 
Secondary Outcome  
Outcome  TimePoints 
lateral internal sphincterotomy is more effective than apamarga ksharasootra  0, 7th , 14th, 21th, 30th day 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "105"
Final Enrollment numbers achieved (India)="105" 
Phase of Trial   N/A 
Date of First Enrollment (India)   19/08/2017 
Date of Study Completion (India) 04/01/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Banothe Gajiram D.& Dudhamal T.S.: Ksharasutra Transfixation And Ligation In The Surgical Management Of Chronic Fissure In-Ano - A Case Report. International Ayurvedic Medical Journal {online} 2019 Gajiram D. Banothe and T. S. Dudhamal. Management of Chronic fissure in ano by Ksharasutra (medicated thread): A Clinical Prospective Study. Int. J. Res. Ayurveda Pharm. 2020;11(4):45-49  
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

SUMMARY

               The research study entitled “A comparative clinical study of Apamarg Ksharasootra and Lateral Internal Sphincterotomy in the management of Parikartika (Chronic Fissure-In-Ano)- An open randomized Trial. ” Aim and Objective of this study was to compare Apamarga Ksharasootra application and Lateral Internal Sphincterotomy in the management of Parikartika (Chronic Fissure-in-ano). This trial is summarized in Literature review, Ayurvedic literature & Modern literature of Parikartika (Chronic Fissure in ano). For this trial Null hypothesis (H0) was the effect of Apamarga Ksharasootra and open lateral internal sphincterotomy  in the management of Parikartika (Chronic fissure in ano) will be same. Alternative hypothesis (H1) was the effect of Apamarg Ksharasootra application and Latral Inernal Sphincterotomy in the management of Parikartika (Chronic fissure in ano) will not be same. Drug review included description of Apamarga Kshara and Ksharasootra Preparation, SOP of Kshara preparation and their ingredients detail with their properties and mode of action were discussed with classical references. Adjuvant drugs was given in both groups were also discussed with their probable mode of action.

Total 105 patients of Parikartika (Chronic Fissure in Ano) were selected & randomly divided by computerized randomized table. In Group A (n=52) patients treated with trial Ksharasootra application with maximum possible anal dilatation was done while in group-B (n=53) Lateral Internal Sphincterotomy (LIS) was done under LA. or S.A. Jatyadi Taila Matra Basti, Panchawalkala Kwatha for Avagaha Swedana, Erandbhrishta Haritaki orally for laxative were used in post-operative period as adjuvant drugs in both groups. Before treatment, routine hematological, biochemical, urine examination were carried out. The assessment was made on the basis of relief in pain, oozing and days required for complete wound healing after operation. In this study, assessment was done on 7th day, 14th day, 21st day and on 30th post-operative day and Follow up was taken after 1 month. The observed results in the study were subjected to statistical calculation to derive final conclusion.

The discussion was made on all demographic observations and clinical findings i.e. In group-A average 11.75 days required for relief in pain in ano while in group-B average 09.84 days required for relief in pain in ano, which shows the patients of Group-B got relief in pain earlier than patients of Group-A. In this study, it was observed that 92.16% patients got relief in post-operative oozing of blood till 1st week in group-A, 100% patients got relief in P/R bleeding within 14th days in group-A and 89.26% patients got relief in P/R bleeding within 7th days in group-B. This means after Sphincterotomy more days required for stoppage of oozing of blood. It was observed that 50.00% patients got relief in post-operative swelling till 1st  week in group-A, 100% patients got relief in post-operative swelling within 14th  days in group-A and 33.33% patients got relief in post-operative swelling within 7th days in group-B and 100% patients got relief in post-operative swelling within 14th days. Vibandha (Constipation) was relieved in 49 patients of Group-A and 48 patients of Group-B have constipated bowel (Vibandha) which  was relieved within 7 days. In 83.50% patients of Group A and 16.49% of patients of Group B needed other laxative drug for relief in constipation after operation.

Conclusion- In both groups highly significant results were found statistically but early relief in post-operative pain were observed in Group-B (Lateral Internal Sphincterotomy with excision of skin tag) whereas early relief in post-operative swelling and oozing were observed in Group-A (Ksharasootra application with maximum possible anal dilatation). 

Hence Null hypothesis (H0) is rejected and Alternative hypothesis (H1) is accepted i.e. a significant effect of Apamarg Ksharasootra application in the management of Fissure in ano.


 
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