Fistula in AnoBhagandarNCT01880398
Management of Fistula in Ano by Kshar Sutra, Para Surgical Procedure.
An observational study of Fistula in Ano, run by Government Ayurved College and Hospital at 1 site in India.
Trial summary
Background: Fistula in ano is one of the most common diseases of the ano rectal region. Treatment of Fistula in ano has puzzled the medical fraternity due to its complex nature. Commonly prevalent surgical treatment for anal Fistula, that is "Fistulectomy" does not provide successful cure for the disease, post… Read more about this study
- Who is it for?
- Ages 48 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fistula in Ano
- What is being tested?
- Kshar Sutra
- How many people
- 1 participants
- Where
- 1 siteIndia
- Study dates
- Jun 2011to Oct 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 48 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Government Ayurved Hospital
Who may be able to join
- Diagnosis of Fistula in ano without tributeries.
Who cannot join
- Multiple fistula and associated ano rectal conditions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Case Study of Fistula in Ano Managed by Kshar Sutra, Para Surgical Procedure
Background: Fistula in ano is one of the most common diseases of the ano rectal region. Treatment of Fistula in ano has puzzled the medical fraternity due to its complex nature. Commonly prevalent surgical treatment for anal Fistula, that is "Fistulectomy" does not provide successful cure for the disease, post operative complications and recurrences being common. Acharya Sushruta an ancient Indian Surgeon has described in his text ' Sushruta Samhita' about an ancient Ayurvedic technique of medicated thread called Ksharsutra treatment for Bhagandara ( Fistula in ano). Treatment of anal Fistula (Bhagandara)and Nadi-Vrana(Sinus) with Ksharsutra was practiced by Sushruta (1000-600B.C.) .
Hypothesis: Aycharya Sushruta advocated Kshar Sutra therapy in Fistula in ano and in various types of Fistula.
Read the detailed description
A 48 years old female patient, came with complaints of painful discharging boil at left side of Perianal region with pain.
She gave a surgical history of incision and drainage for gluteal abscess done in before four month. On local examination Patient had discharging sinus at 3 o' clock position on left side of Perianal region. Before planning the treatment other aetiologies were ruled out.
Diagnosis was confirmed by Fistulogram, suggestive of high anal fistula with internal opening in the anal canal. Under spinal anaesthesia probing was done. Internal opening of Fistula was confirmed by injecting Methylene Blue dye through external opening. The track was directed upward in the anal canal without any tributaries. Length of the tract was 9cm.
Then Kshar Sutra was tied covering the entire underlying track for cutting and healing under all aseptic precaution. The patient was discharged on the next day of procedure. The Kshar Sutra was changed weekly. To promote healing and to reduce pain and inflammation oral antibiotics, anti-inflammatory medicine were also prescribed.
The total period of Kshar Sutra treatment was 5 month. The Kshar Sutra was a standard medicated thread smeared with Kshar of Apamarga (Achyranthus aspera), Shnuhi (Eforbia Nerrifolia) which has quality of cutting and Haridra(Curcuma Longa) which is used as a antiseptic. The ph value of the thread thus prepared was determined and its sterilization effected by ultraviolet rediation. The alkalinity of Kshar Sutra was 9.2ph.
- Conditions
- Fistula in Ano
- Being tested
- Kshar Sutra
- Keywords
- FIstula in ano; Bhagandar
- Medical subject headings
- Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kshar SutraOther
Also called Medicated Thread
The Kshar Sutra was a standard medicated thread smeared with Kshar of Apamarga (Achyranthus aspera), Shnuhi (Eforbia Nerrifolia) which has quality of cutting and Haridra(Curcuma Longa) which is used as a antiseptic. The ph value of the thread thus prepared was determined and its sterilization effected by ultraviolet radiation. The alkalinity of Kshar Sutra was 9.2ph.
| Study group | Role | What they receive |
|---|---|---|
| Kshar Sutra | The Kshar Sutra was a standard medicated thread smeared with Kshar of Apamarga (Achyranthus aspera), Shnuhi (Eforbia Nerrifolia) which has quality of cutting and Haridra(Curcuma Longa) which is used as a antiseptic. The ph value of the thread thus prepared was determined and its sterilization effected by ultraviolet radiation. The alkalinity of Kshar Sutra was 9.2ph. Receives: Other: Kshar Sutra |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Kshar sutra in Fistula in ano
Cutting and healing of the Fistula track.
Measured: 5month
Secondary outcomes (1)
Recurrence of Fistula in ano
By observing patient for 1 year.
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2013 (estimated)
- Study startJun 2011
- Primary completionOct 2011
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fistula in AnoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Government Ayurved College and Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr.Nita Mahadevrao Kedar, Government Ayurved College and Hospital
- Investigators
- Nita M Kedar, M.S.(Ayu), Principal investigator, Government Ayurved Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01880398
- Sponsor's protocol ID
- 2468
- Acronym
- Bhagandar
- Status last verified
- Dec 2013
- First submitted
- 9 Jun 2013
- Last updated
- 24 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Case Study of Fistula in Ano Managed by Kshar Sutra, Para Surgical Procedure
- ClinicalTrials.gov ID
- NCT01880398
- Acronym / sponsor ID
- Bhagandar / 2468
- Conditions
- Fistula in Ano
- Keywords
- FIstula in ano; Bhagandar
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Government Ayurved College and HospitalOther government
- Study start
- Jun 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 19 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Fistula in ano is one of the most common diseases of the ano rectal region. Treatment of Fistula in ano has puzzled the medical fraternity due to its complex nature. Commonly prevalent surgical treatment for anal Fistula, that is "Fistulectomy" does not provide successful cure for the disease, post operative complications and recurrences being common. Acharya Sushruta an ancient Indian Surgeon has described in his text ' Sushruta Samhita' about an ancient Ayurvedic technique of medicated thread called Ksharsutra treatment for Bhagandara ( Fistula in ano). Treatment of anal Fistula (Bhagandara)and Nadi-Vrana(Sinus) with Ksharsutra was practiced by Sushruta (1000-600B.C.) .
Hypothesis: Aycharya Sushruta advocated Kshar Sutra therapy in Fistula in ano and in various types of Fistula.
Detailed description
A 48 years old female patient, came with complaints of painful discharging boil at left side of Perianal region with pain.
She gave a surgical history of incision and drainage for gluteal abscess done in before four month. On local examination Patient had discharging sinus at 3 o' clock position on left side of Perianal region. Before planning the treatment other aetiologies were ruled out.
Diagnosis was confirmed by Fistulogram, suggestive of high anal fistula with internal opening in the anal canal. Under spinal anaesthesia probing was done. Internal opening of Fistula was confirmed by injecting Methylene Blue dye through external opening. The track was directed upward in the anal canal without any tributaries. Length of the tract was 9cm.
Then Kshar Sutra was tied covering the entire underlying track for cutting and healing under all aseptic precaution. The patient was discharged on the next day of procedure. The Kshar Sutra was changed weekly. To promote healing and to reduce pain and inflammation oral antibiotics, anti-inflammatory medicine were also prescribed.
The total period of Kshar Sutra treatment was 5 month. The Kshar Sutra was a standard medicated thread smeared with Kshar of Apamarga (Achyranthus aspera), Shnuhi (Eforbia Nerrifolia) which has quality of cutting and Haridra(Curcuma Longa) which is used as a antiseptic. The ph value of the thread thus prepared was determined and its sterilization effected by ultraviolet rediation. The alkalinity of Kshar Sutra was 9.2ph.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kshar Sutra | – | Other: Kshar SutraThe Kshar Sutra was a standard medicated thread smeared with Kshar of Apamarga (Achyranthus aspera), Shnuhi (Eforbia Nerrifolia) which has quality of cutting and Haridra(Curcuma Longa) which is used as a antiseptic. The ph value of the thread thus prepared was determined and its sterilization effected by ultraviolet radiation. The alkalinity of Kshar Sutra was 9.2ph. |
Who may qualify
- Ages
- 48 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Government Ayurved Hospital
Key inclusion criteria (1 listed)
- Diagnosis of Fistula in ano without tributeries.
Key exclusion criteria (1 listed)
- Multiple fistula and associated ano rectal conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kshar SutraAlso: Medicated ThreadThe Kshar Sutra was a standard medicated thread smeared with Kshar of Apamarga (Achyranthus aspera), Shnuhi (Eforbia Nerrifolia) which has quality of cutting and Haridra(Curcuma Longa) which is used as a antiseptic. The ph value of the thread thus prepared was determined and its sterilization effected by ultraviolet radiation. The alkalinity of Kshar Sutra was 9.2ph. | Other | Kshar Sutra |
Primary outcome
Efficacy of Kshar sutra in Fistula in ano
Time frame: 5month
Cutting and healing of the Fistula track.
1 secondary outcome
Recurrence of Fistula in ano
Time frame: 1year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nita M Kedar, M.S.(Ayu) principal investigator
Government Ayurved Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fistula in Ano, run by Government Ayurved College and Hospital at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of Kshar sutra in Fistula in ano (time frame: 5month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2013.