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CTRI Number  CTRI/2017/03/007980 [Registered on: 01/03/2017] Trial Registered Prospectively
Last Modified On: 12/07/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To compare treatment of Fistula in Ano (Bhagandar)by ksharsutra( medicated thread) and laying open of fistula tract with kshar application(Alkaline Herbal paste) 
Scientific Title of Study   “A Comparative Clinical Study of Fistulotomy along with Ksharkarma and Ksharsutra Application in the Management of Bhagandara (Fistula-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  Monica Shrestha 
Designation  PhD Scholar 
Affiliation  Institute of postgraduate training and reasearch in Ayurveda, Jamnagar 
Address  OPD no 1, Department of Shalyatantra , IPGT and RA , Jamnagar , Gujrat

Jamnagar
GUJARAT
361008
India 
Phone  8422913401  
Fax    
Email  shresthamonica33@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  
Address  Associate professor Department of Shalyatantra Institute for Post Graduate Teaching And Research In Ayurveda ,Gujarat Ayurved University ,Jamnagar- 361008

Jamnagar
GUJARAT
361008
India 
Phone  9428671939  
Fax  02882676856  
Email  drtsdudhamal@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr T S Dudhamal 
Designation  Associate Professor 
Affiliation  Institute for Post Graduate Teaching And Research In Ayurveda  
Address  Associate proffesor, Department of Shalyatantra, Institute for Post Graduate Teaching And Research In Ayurveda ,Gujarat Ayurved University ,Jamnagar- 361008

Jamnagar
GUJARAT
361008
India 
Phone  9428671939  
Fax  02882676856  
Email  drtsdudhamal@gmail.com  
 
Source of Monetary or Material Support  
Institute for Post Graduate Teaching And Research In Ayurveda ,Gujrat Ayurveda University , Jamnagar , Gujrat-361008 
 
Primary Sponsor  
Name  Institute for Post Graduate Teaching And Research In Ayurveda  
Address  Institute for Post Graduate Teaching And Research In Ayurveda Gujarat Ayurved University Jamnagar 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 
Dr Monica Shrestha  Institute of Postgraduate training and Research in Ayurveda   Opd no 1 , Department of Shalyatantra ,Institute of Postgraduate training and Research in Ayurveda Gujrat Ayurveda University Jamnagar-361008
Jamnagar
GUJARAT 		 8422913401

SHRESTHAMONICA33@GMAIL.COM 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K603||Anal fistula, diagnosed case of Low Fistula in Ano,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  GROUP A  Fistulotomy followed by teeksna kshar application, under L.A/S.A Daily dressingof post fistulotomy wound with ksharplota for 7 days, if needed dressing with ksharplota will be done for next 7 days.  
Comparator Agent  GROUP B  Kshrasutra application under L.A. /S.A Ksharshutra will be changed every week till cut through of complete track  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Diagnosed cases of Low anal Fistula.
Patients of Bhagandar, as mentioned above, and those medically fit for surgery irrespective of sex, caste, religion & occupation.
 
 
ExclusionCriteria 
Details  Crohns disease
Uncontrolled Diabetes Melitus
Uncontrolled Hypertention
Cardiovascular disease
Pregnancy
Malignancy
Rectal prolapse
Hepatitis B, Tuberculoses, HIV & VDRL positive cases
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
healing of fistulous tract  healing of fistulous tract and post operative wound size 
 
Secondary Outcome  
Outcome  TimePoints 
Not Applicable  Not Applicable 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "106"
Final Enrollment numbers achieved (India)="106" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   01/03/2017 
Date of Study Completion (India) 17/09/2018 
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   not yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  
In clinical study, patients of Bhagandara were selected and randomly allocated using computerised randomisation table into two groups. In Group- A (n=53) patients were treated by Fistulotomy with Kshara application, while in Group-B (n=53) patients were treated with Ksharsutra application. In both groups adjuvant treatment was Varuna Shigru Guggulu vati 1gm TDS, Panchvalkal kwath for sitz bath BD and Jatayadi tail matrabasti once in a day was given till completion of treatment. For that purpose selected patients were subjected to detailed history taking on the basis of specially prepared performa. Routine haematological biochemical, urine and stool examinations were carried out before the treatment for preoperative assessment and fitness. Pre Operative and Post operative TRUS (Trans rectal ultrasonograph ) was done for evidence of healing of fistula. The postoperative treatment was similar in both groups. In Group A dressing was done with Kshar plota (gauze dipped in ksharjala) till the post operative wound had slough on it, followed by dressing with gauze socked in normal saline. In Group B the tract was flushed with Ksharjala every day and Ksharsutra was changed by rail road method every week till the Ksharsutra got cut through.
The effect of the therapies was assessed on the basis of relief in subjective criteria (pain, discharge and itching) and assessment of objective criteria i.e Lenth of Ksharsutra in group B and Length of post operative wound in Group A. Followup was taken after 1 month of healing of post operative wound and post operative TRUS was done. The observed results in the study were assessed statistically to derive final results.
102 out of 106 patients of two groups had completed the treatment and 4 dropped out from study for personal reasons (One patient dropped out from Group A while 3 patients dropped out from Group B).

OBSERVATIONS:
Observation made in the clinical study are summarised as follow
ï‚· In this study maximum patients were male (88.7), in the age group of 41 to 50 years (33.9%) and married (83.9 %).
ï‚· The patients belonged to urban habitat were 65%
ï‚· Maximum patients had vegetarian diet 60.4%
ï‚· 72.6% belonged to middle class
ï‚· 88.7% belonged to Hindu religion while others were muslim.
ï‚· In cardinal symptoms maximum patients had complain of pain (93.4%) followed by discharge (83%).
ï‚· Maximum numbers of patients reported the Chronicity early duration that 0-3 months (42.4% )
ï‚· Single external opening was found in 86.8% and the initial length of tract up to 4cm in 88.7% was observed in maximum patients.
 In most of the cases external openings were found at 6 o’clock position (32% ). That is posterior half of anus.
ï‚· The complete low anal type of fistula-in-ano were found in maximum patients (89.6%) out of which 40.6 % had Intersphincteric fistula and Transphincteric Fistula

RESULT

 Comparison of mean change in pain score from before to after treatment periods showed that there was significant (p=0.0001) mean change in pain score in both the groups. However, the mean change in pain score was higher in Group A (3.64±2.06) than Group B (3.22±2.41).
ï‚· The comparison of mean pain score between the groups across the time periods showed that pain score was significantly (p<0.05) different at most of the time periods ( 1st week, 2nd week, 3rd week, 4th week, 5th week, 6th week and AT).

ï‚· The comparison of improvement in pain, discharge and itching between the groups from before treatment to at the end of treatment showed that pain was improved in 96.1% patients of Group A and 96% of Group B. Discharge was improved in 100% patients of Group A and 96% patients of Group B. Itching was improved in 98.1% patient of Group A and 94% patient of Group B.
 The comparison of time taken for wound healing between the groups showed that time of healing was significantly (p=0.004) lower among the patients of Group A (4.80±2.42) than Group B (4.80±2.42).
ï‚· In Group B, Mean Unit Cutting Time was 7.45 days/cm

Overall Effect Of Therapy

The comparison of overall improvement between the groups. Complete healing was among 90.6% of Group A and 75.5% of Group B. There was no significant (p>0.05) difference in healing between the groups.
DISCUSSION:
In the research work 88.7% patient were in their fourth decade of life and there was significant male predominance which is in accordance with the other studies in India and world. Most patient belonged to urban habitat and hindu religion as Jamnagar is hindu dominant city.
The relative distribution of Intersphincteric and transsphincteric fistulae is also consistent with the previous studies. (Sainio P etal) In most of the cases external openings were found at 6 o’clock position (34.9% ). That is posterior half of anus. Posterior wall of anal canal is more fixed to surrounding musculature than anterior wall. Another cause might be due to fixity of posterior wall there is more chance of stagnation of infection, which infects an anal gland of posterior wall. In classics it is mentioned that the anal glands are 4-8 in number and most of them are situated at posterior portion of anal canal.
Early relief in pain, discharge and itching was observed in Group A compared to Group B but no significant difference was seen in the criterias after treatment which may be because in Group B there is constant cutting and debridement of fistulous tract during treatment which results into pain and dicharge.

The mean duration of healings of fistula is less in Group A compared to Group B clearly indicated that in the trial group ( Fistulotomy with Ksharkarma) healing time is earlier as compared to Group B which may be because most of the unhealthy granulation tissue is removed during fistulotomy and what is left is debired by the Tikshna Kshara. Fistulotomy helps in complete drainage of the fistulous tract and abscess cavity and Tikshna Kshara debrides the unhealthy granulation and fibrous tissue at the base of the tract. It also cauterizes the branches which may be left undetected, thus preventing recurrence.
While in Group B the healing time is delayed as compared to Group A might be as the tract is cut by the Ksharsutra and there is delayed healing of wound after cut through, because Ksharsutra is a foreign material for the body so there is hypergranulation after the cut through of Ksharsutra. Thus, healthy granulation takes time to develope and therefore the healing of post Ksharsutra wound is delayed.
The adjuvant therapy was similiar in both groups. Panchvalkal kwath sitz bath helped to clean the pus discharge and associated debris from the tract and promoted drainage of pus from the tract. It helped to reduce local congestion and inflammation and thus relived associated pain by enhancing local circulation which is necessary to promote healing and oil itself is vatashamak in nature so reduces pain and it also lubricates the anal canal preventing constipation, eases the passage of stool and promotes wound healing. Varuna shigru guggulu has antibacterial and anti inflammatory properties so reduced pain and prevented infection
 
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