| CTRI Number |
CTRI/2024/10/075778 [Registered on: 24/10/2024] Trial Registered Prospectively |
| Last Modified On: |
22/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To know the effect of gunja kshara sutra with apamarga kshara sutra in the management of fistula |
|
Scientific Title of Study
|
A randomized controlled clinical Study to evaluate the efficacy of Gunja Ksharasutra with Apamarga Ksharasutra in the patients of Bhagandhara(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 |
Dudekula Shareef |
| Designation |
Post graduate scholar |
| Affiliation |
S.V Ayurvedic College and Hospital |
| Address |
Department of Shalya Tantra, S.V Ayurvedic College and Hospital, Tirupati, Chittoor, Andhra Pradesh, pin 517501.
Chittoor ANDHRA PRADESH 517501 India |
| Phone |
9490294810 |
| Fax |
|
| Email |
shareefdudekula2010@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr K V Vijaya Bhaskara Reddy |
| Designation |
PROFESSOR AND HOD |
| Affiliation |
S.V Ayurvedic College and Hospital |
| Address |
Department of Shalya Tantra, S.V Ayurvedic College and Hospital, Tirupati, Chittoor, Andhra Pradesh, pin 517501.
Chittoor ANDHRA PRADESH 517501 India |
| Phone |
9849451333 |
| Fax |
|
| Email |
drkvbreddy@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dudekula Shareef |
| Designation |
Post Graduate Scholar |
| Affiliation |
S.V Ayurvedic College and Hospital |
| Address |
Department of Shalya Tantra, S.V Ayurvedic College and Hospital, Tirupati, Chittoor, Andhra Pradesh, pin 517501.
Chittoor ANDHRA PRADESH 517501 India |
| Phone |
9490294810 |
| Fax |
|
| Email |
shareefdudekula2010@gmail.com |
|
|
Source of Monetary or Material Support
|
| S.V Ayurvedic College and Hospital |
|
|
Primary Sponsor
|
| Name |
S.V Ayurvedic College and Hospital |
| Address |
Near SVIMS campus, Tirupati, Chittoor, Andhra Pradesh, pin 517501 |
| 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 Shareef |
S.V Ayurvedic college and Hospital |
Department of Shalya Tantra,
Op no.5,Near SVIMS campus, Tirupati, Chittoor, AP 517501 Chittoor ANDHRA PRADESH |
9490294810
shareefdudekula2010@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of TTDs S.V. Ayurvedic College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K603||Anal fistula. Ayurveda Condition: BAGANDARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | kShArasUtra, कà¥à¤·à¤¾à¤°à¤¸à¥‚तà¥à¤° | (Procedure Reference: Charaka Chikitsa12/96-97, Susruta chikitsa 17/32, Procedure details: Procedure details:
The study will be carried out in three phases.
Phase 1: Preparation of Gunja Kshara Sutra, Preparation of specific record sheets. Identification of cases, diagnosis, scrutinizing, registration & grouping.
Phase 2:
Application of Kshara Sutra under Local Anesthesia by probing from external opening & taking out of probe from internal opening by applying kshara sutra.Change of Kshara Sutra will be done every week by railroad technique till the complete cut open of the tract.
Phase 3: Healing of the whole tract. Follow up after the complete healing for 2 months with 15 days intervals. Evaluation, documentation, & statistical unPaired t-test & p-values to check level of significance.)
| | 2 | Comparator Arm | Procedure | - | kShArasUtra, कà¥à¤·à¤¾à¤°à¤¸à¥‚तà¥à¤° | (Procedure Reference: Charaka Chikitsa12/96-97, Susruta chikitsa 17/32, Procedure details: Procedure details:
The study will be carried out in three phases.
Phase 1: Preparation of Apamarga Kshara Sutra. Preparation of specific record sheets. Identification of cases, diagnosis, scrutinizing, registration & grouping.
Phase 2: Application of Kshara Sutra under Local Anesthesia & applying the Kshara sutra by probing from external opening & taking out of probe from internal opening by applting ksharasutra. Change of Kshara Sutra will be done every week by rail raod technique till the complete cut open of the tract.
Phase 3: Healing of the whole tract. Follow up after the complete healing for 2 months with 15 days intervals. Evaluation, documentation & statistical unPaired t-test & p-values to check level of significance. )
|
|
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients irrespective of Gender and religion from
the age group of 20 to 60 years.
2. Patients Patients with signs and symptoms of
Bhagandhara.
3. Patients who are diagnosed as Fistula-in-ano. |
|
| ExclusionCriteria |
| Details |
1. Concomitant Ano-rectal conditions like
ulcerative colitis, malignancy, Crohn’s
disease, multiple fistulae.
2. Pregnancy.
3. Tuberculosis.
4. Obstructive Uropathies.
• Systemic diseases like CAD, Portal hypertension.
• Patients with controlled blood sugars. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Accessing the pain, discharge, itching, unit cutting time and tenderness for every week until cut open of a track. The efficacy is calculated by comparing the both subjecive and objective parameters of both ksharasutras each other.
|
Once a week, following the replacement of an existing ksharasutra, until the entire track is cut open.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Complete healing time, reoccurrences & any other complications like incontinency, discharge, etc. |
After the entire track is cut open, follow up with a patient for 2 months with an interval of 15 days. |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
02/11/2024 |
| 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="6" 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
|
Bhagandhara can be compared with Fistula-in-ano in terms of
clinical features and treatment. The word fistula is derived from the Latin
word a Reed, pipe, or flute. It implies a chronic granulating Track connecting
two epithelial-lined surfaces. These Surfaces may be cutaneous or mucosal. The
main Cause known for fistula-in-ano is a crypto glandular Infection of anal
crypts. The anal fistula is a single Track with an external opening in the skin
of the peri- Anal region and an internal opening in the modified Skin or mucosa
of the anal canal or rectum. Various operative procedures often lead to
complications like recurrence, Anal incontinence, infections, etc. The
prevalence rate is 8.6 cases per 1000 population. The male-to-female ratio is
about 1.8:1. It is categorized as a surgical domain which still to date is
where surgeons have been struggling for centuries with its incurable with
recurrence rate of 30%-40%. Acharya
Sushruta described Bhaishajya chikitsa, Kshara karma, Agni Karma, and Shastra
Karma chikitsa for anorectal Diseases. Kshara karma comes under anusastra which
is defined as hina sastra (sub-surgical condition) or shaly sadrusya(similar to
a surgical instrument), used like a surgical instruments but with lesser
invasion and stress on the patients. Bhagandara is a Chedya (excision) vyadhi.
The Ksharasutra is a Para-surgical measure capable to perform excision slowly
by virtue of its mechanical pressure and chemical action in Bhagandara because
the kshara possesses the qualities of chedana, bhedana, lekana, and
tridoshahara.
kshara sutra is mentioned in the textual references
of Chakradatta and Rasatarangini where we get only indication of a thread made
up of snuhi, apamarga and haridra. Acharya Susrutha mentioned 23 types of
plants useful for kshara karma (sus. su 11/11) like gunja, palasha, kutaja,
and Gunja14. Need for the study: Kshara sutra is a successful novel drug
delivery system in managing the cases of fistula-in ano but it has certain
clinical problems like Pain, Burning sensation, Inflammation, duration for the
complete cutting of the track anf finally complete healing time. Scope of the study:
Gunja has tridoshahara properties which will works on
all the doshas and helps to minimize adverse effects like inflammation,
itching, burning sensation, pain and thereby decreases uct (unit cutting time)
followed by fast healing of the wound. Gunja plant available in all seasons, it
can be cultivated easily and economically. This study helps to develop a
alternate standard Gunja kshara sutra along with Apamarga kshara sutra. |