| CTRI Number |
CTRI/2024/10/074658 [Registered on: 03/10/2024] Trial Registered Prospectively |
| Last Modified On: |
02/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical Trial Proposal : Efficacy of Madhu based Tankana Ksharasutra vs.Snuhi based Apamarga Ksharasutra in Patients with Bhagandhara (Fistula in ano) |
|
Scientific Title of Study
|
Comparative clinical study on the effect of madhu based tankana ksharasutra and standard apamarga ksharasutra in bhagandara( fistula in ano) |
| 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 Ancitta Jose |
| Designation |
Pg Scholar- Department of Shalya Tantra |
| Affiliation |
Sri Dharmastala Manjunatheshwara College of Ayurveda and Hospital Hassan |
| Address |
SDM College of Ayurveda and Hospital Hassan Sri Dharmastala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 Hassan KARNATAKA 573201 India |
| Phone |
9496936056 |
| Fax |
|
| Email |
ancittajose@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Mahesh Kumar E S |
| Designation |
Associate Professor - Department of Shalya Tantra |
| Affiliation |
Sri Dharmastala Manjunatheshwara College of Ayurveda and Hospital Hassan |
| Address |
SDM College of Ayurveda and Hospital Hassan Sri Dharmastala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 Hassan KARNATAKA 573201 India |
| Phone |
8073851473 |
| Fax |
|
| Email |
drmaheshkumar@sdmcahhassan.org |
|
Details of Contact Person Public Query
|
| Name |
Dr Mahesh Kumar E S |
| Designation |
Associate Professor - Department of Shalya Tantra |
| Affiliation |
Sri Dharmastala Manjunatheshwara College of Ayurveda and Hospital Hassan |
| Address |
Sri Dharmastala Manjunatheshwara College of Ayurveda and Hospital Hassan Sri Dharmastala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 Hassan KARNATAKA 573201 India |
| Phone |
8073851473 |
| Fax |
|
| Email |
drmaheshkumar@sdmcahhassan.org |
|
|
Source of Monetary or Material Support
|
| Sri Dharmastala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan-573201 Karnataka India |
|
|
Primary Sponsor
|
| Name |
Sri Dharmastala Manjunatheshwara College of Ayurveda and Hospital Hassan |
| Address |
Sri Dharmastala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan-573201 India |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mahesh Kumar E S |
Sri Dharmastala Manjunatheshwara College of Ayurveda and Hospital Hassan |
OPD number 11 Department of Shalya Tantra
Sri Dharmastala Manjunatheshwara College of Ayurveda and Hospital Hassan Hassan KARNATAKA |
8073851473
drmaheshkumar@sdmcahhassan.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL, HASSAN |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K605||Anorectal fistula, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Madhu based Tankana Ksharasutra |
First the patient will be kept in lithotomy position after Local/Spinal anaesthesia perianal region will be cleaned with antiseptic lotions and draped. Later gloved finger will gently be introduced into the rectum. Then a suitable selected probe will be passed through the external opening of fistula. The tip of the probe will be forwarded along the path of least resistance and will be guided by the finger in rectum to reach into the lumen of anal canal through the internal opening and its tip will be finally directed to come out of anal orifice. Then a suitable length of Madhu based Tankana Kshara Sutra will be taken and threaded into the eye of probe. Thereafter the probe will be pulled out through the anal orifice, to leave the thread behind in the fistulous track. The two ends of the thread will be then tied together with a moderate tightness outside the anal canal |
| Comparator Agent |
Standard Apamarga Ksharasutra |
First the patient will be kept in lithotomy position after local/spinal anaesthesia perianal region will be cleaned with antiseptic lotions and draped. Later gloved finger will gently be introduced into the rectum. Then a suitable selected probe will be passed through the external opening of fistula. The tip of the probe will be forwarded along the path of least resistance and will be guided by the finger in rectum to reach into the lumen of anal canal through the internal opening and its tip will be finally directed to come out of anal orifice. Then a suitable length of Madhu based Apamarga Kshara Sutra will be taken and threaded into the eye of probe. Thereafter the probe will be pulled out through the anal orifice, to leave the thread behind in the fistulous track. The two ends of the thread will be then tied together with a moderate tightness outside the anal canal |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Clinical signs and symptoms of all types of Bhagandara
2.Recurrent Fistula- in-ano
3.Patients who give written surgical consent
4.Patients fit for surgery
5.Patients above the age of 18 years and below 60 years irrespective of caste, gender, religion and socio-economic status.
|
|
| ExclusionCriteria |
| Details |
1.Patients with secondary fistula due to Ulcerative colitis, Crohns disease, Tuberculosis, Hidradenitis Suppurativa, Carcinoma of rectum& anal canal
2.Patients with Retro and HBsAg positive
3.Pregnancy and lactating women
4.Patients with impaired cardiac, renal and hepatic function.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Unit Cutting Time of Fistulous Track |
assessment will be done at baseline, followed by weekly assessment until the fistula tract is completly healed |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pain
Discharge
Granulation tissue
Size of wound |
will be assessed baseline, followed by weekly follow up every week until the fistula tract heals |
|
|
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 |
|
Date of First Enrollment (India)
|
13/10/2024 |
| 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="1" Months="1" 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
|
Bhagandara is second common disease occurring in ano-rectal region after haemorrhoids. The word Fistula is derived from a Latin word reed, pipe or flute. It implies a chronic granulation track connecting two epithelial lined surfaces. The prevalence rate of fistula-in-ano is 8.6 cases per 1 lakh population. The prevalence in men is 12.3 and in women is 5.6 cases per 1 lakh population. The male-to-female ratio is 1.8:1. The mean age of patients is 38.3 years. It is considered as one among the Mahagada in Sushruta Samhita. In Ayurveda Ksharasutra application is well known for management of Bhagandara. Though in this disease many Ksharasutras tried, Apamarga Ksharasutra is widely being practiced. When go through the classics we get reference regarding Tankana grouped into Kshara Dravyas. This Tankana is not widely practiced. Apamarga is very effective but preparation of this Apamarga Kshara is not at all easy process. It needs burning of lots of Apamarga plants,then processing including boiling etc, and the end we get a little quantity of final product. In other hand Tankana, as per reference, is also a Kshara, cost effective and abundantly available. It minimizing the problems like burning sensation, local irritation during the course of therapy. Madhu has Vranaropaka properties as per the principles of the sixty Upakramas of Vrana management described in Susrutha Samhitha . The authors like Chakrapani, Susruta, Bhavaprakasha, Vangasena and Yogaratnakara have described the qualities of Madhu as Vranashodhana, Vranaropana, Lekhana, Sandhana, Varnya, Srotovishodana, Yogavahi.. Advantages of Kshara Sutra Therapy: Simple and safe parasurgical procedure, cost-effective and ambulatory, minimal recurrence rate, no surgical complications like incontinence, stenosis and stricture. Snuhi Ksheera based Apamarga ksharasutra is the standard one and is proved effective treatment in the management of Fistula-in-ano. But, burning sensation, local irritation during the course of therapy and difficulty of manufacturing process has limited its use. To overcome these problems, I have taken the study of Madhu based Tankana Kshara sutra for better action, availability and acceptability. Madhu based Tankana Kshara sutra will be prepared by the same method as that of Snuhi Apamarga Kshara Sutra. So, the present study has been taken up to know the efficacy of Madhu based Tankana Kshara Sutra in the management of Bhagandhara. |