| CTRI Number |
CTRI/2019/09/021318 [Registered on: 18/09/2019] Trial Registered Prospectively |
| Last Modified On: |
14/09/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
AYURVEDIC MANAGEMENT OF FISTULA-IN-ANO BY KSHARA SUTRA |
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Scientific Title of Study
|
A CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFECTIVENESS OF ARKAKSHEERA BASED ARKAKSHARASUTRA AND APAMARGA KSHARA SUTRA IN BHAGANDARA WITH SPECIAL REFERENCE TO FISTULA-IN-ANO
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| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nagashree H Krishna |
| Designation |
Shalya Tantra P G Scholar |
| Affiliation |
Government Ayurveda Medical College |
| Address |
OPD No. 6 of Sri Jayachamarajendra Institute of Indian Medicine and Hospital . Department of Post Graduate Studies in Shalya Tantra, Govenment Ayurveda Medical College, Dhanwantari Road Bengaluru
Bangalore
KARNATAKA
560010
India |
| Phone |
09481865404 |
| Fax |
|
| Email |
nagayurveda@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shilpa P N |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurveda Medical College |
| Address |
Department of Post Graduate Studies in Shalya Tantra, Govenment Ayurveda Medical College, Dhanwantari Road Bengaluru
Bangalore
KARNATAKA
560010
India |
| Phone |
9886792113 |
| Fax |
|
| Email |
drshilpamys@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nagashree H Krishna |
| Designation |
Shalya Tantra P G Scholar |
| Affiliation |
Government Ayurveda Medical College |
| Address |
OPD No. 6 of Sri Jayachamarajendra Institute of Indian Medicine and Hospital . Department of Post Graduate Studies in Shalya Tantra, Govenment Ayurveda Medical College, Dhanwantari Road Bengaluru
Bangalore
KARNATAKA
560010
India |
| Phone |
09481865404 |
| Fax |
|
| Email |
nagayurveda@gmail.com |
|
|
Source of Monetary or Material Support
|
|
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Primary Sponsor
|
| Name |
Dr Nagashree H Krishna |
| Address |
OPD No. 6 of Sri Jayachamarajendra Institute of Indian Medicine and Hospital . Department of Post Graduate Studies in Shalya Tantra, Govenment Ayurveda Medical College, Dhanwantari Road Bengaluru |
| Type of Sponsor |
Other [Self] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nagashree H Krishna |
Sri Jayachamarajendra Institute of Indian Medicine |
OPD No. 06
Department of Shalya Tantra
Sri Jayachamarajendra Institute of Indian Medicine Government Ayurveda Medical College Campus Dhanwantari Road Bengaluru
Bangalore
KARNATAKA |
9481865404
nagayurveda@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical CommitteeGAMC Bengaluru |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K605||Anorectal fistula, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Arka Ksheera based Arka Kshara Sutra |
Initially Probing and Primary threading done. on 7th Day primay thread is replaced by Arka Ksheera based Arka Kshara Sutra. The same is continued every 7th day till the tract is cut |
| Comparator Agent |
Snuhi ksheera based Apamarga Kshara Sutra |
Initially Probing and Primary threading done. on 7th Day primay thread is replaced by Snuhi ksheera based Apamarga Kshara Sutra. The same is continued every 7th day till the tract is cut |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Irrespective of religion, occupation and duration of symptoms
Patients with clinical features of Fistula-in-ano namely pain, sero-purulent discharge from the tract and pruritis ani, confirmed by clinical examinations and investigations
patient with patent fistulous tract confirmed by probing |
|
| ExclusionCriteria |
| Details |
Diagnosed cases of Fistula in ano secondary to Tuberculosis, Osteomyelitis and malignancies
Associated with other diagnosed anorectal disorders
Pregnancy and lactation mother
Patients suffering with other diagnosed systemic disorders
Recurrent fistula in ano after previous surgery |
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
Unit Cutting Time
Pus Discharge |
Outcome is assessed on the 7th day after Probing and Primary threading and on every week while changing kshara sutra till the Fistulus tract is completely cut |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Pain |
Outcome is assessed on 7th day of kshara sutra insertion |
|
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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
|
N/A |
|
Date of First Enrollment (India)
|
21/09/2019 |
| 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="8"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
Bhagandara is one among common ailments pertaining to guda. In Sushruta Samhita ‘Bhagandara’ is told as Mahagada due to its grave nature 1 . In contemporary medical science, description of Fistula-in-ano, which can be correlated with Bhagandara - is an unhealthy track with an external opening in the skin of perianal region and an internal opening in the modified skin or mucosa of anal canal or rectum. Fistula-in-ano is considered second to Hemorrhoids among all ano-rectal abnormalities. The disease is prevalent all over the world and its occurrence in London Hospital (Study by Marks & Richie, 1977) was reported to be 10% of all in patients and 4% of all new out patients. Study in India (Raghavaiah, 1976) reported anal fistula to constitute 1.6% of all surgical admissions. Eminent surgeons have reported 67.9% - 85% recurrence. These statistical data reveal the fact that treatment of anal fistula is still far from the success and needs a vital reconsideration. Acharya Sushruta has explained surgical procedure to combat the disease. But there is always a risk of recurrence. Ksharasutra is first explained by Acharya Chakrapanidatta 2 and is one such reliable treatment. Acharya Sushruta mentioned the application of ksharasutra in Nadi vrana 3 . Though Apamarga Kshara sutra is considered standard, problems are faced during collection (seasonal) and preservation of Snuhiksheera, and also in course of Kshara sutra treatment like local skin irritations and pain. To overcome these disadvantages ARKAKSHEERA BASED ARKA KSHARASUTRA is being tried in the present study. |