| CTRI Number |
CTRI/2025/03/083184 [Registered on: 24/03/2025] Trial Registered Prospectively |
| Last Modified On: |
21/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clincal trial on Gowri Chinthamani Chendooram and Pachai ennai for Powthiram (Fistula-in-Ano) |
|
Scientific Title of Study
|
A Clinical trial to determine the effectiveness of Gowri Chinthamani Chendooram (Internal) and Pachai ennai (External) in the management of Powthiram (fistula-in-ano) among patients attending Ayothidoss pandithar Hospital,National Institute of Siddha. |
| Trial Acronym |
Anal fistula |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abirami S |
| Designation |
Pg scholar |
| Affiliation |
National Institute Of Siddha |
| Address |
Room no 7/8,Department of maruthuvam,National Institute Of Siddha,Tambaram Sanatorium,Chennai. Room no 7/8,Department of maruthuvam,National Institute Of Siddha,Tambaram Sanatorium,Chennai. Chennai TAMIL NADU 600047 India |
| Phone |
9597350346 |
| Fax |
|
| Email |
abiramisammu@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr H Vetha Merlin Kumari |
| Designation |
Professor |
| Affiliation |
National Institute Of Siddha |
| Address |
Room no 7/8,Department of maruthuvam,National Institute Of Siddha,Tambaram Sanatorium,Chennai. Room no 7/8,Department of maruthuvam,National Institute Of Siddha,Tambaram Sanatorium,Chennai. Chennai TAMIL NADU 600047 India |
| Phone |
9894782366 |
| Fax |
|
| Email |
dr.vetha@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Vetha Merlin Kumari |
| Designation |
Professor |
| Affiliation |
National Institute Of Siddha |
| Address |
Room no 7/8,Department of maruthuvam,National Institute Of Siddha,Tambaram Sanatorium,Chennai. Room no 7/8,Department of maruthuvam,National Institute Of Siddha,Tambaram Sanatorium,Chennai. Chennai TAMIL NADU 600047 India |
| Phone |
9894782366 |
| Fax |
|
| Email |
dr.vetha@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Siddha,Tambaram Sanatorium,Chennai-47 |
|
|
Primary Sponsor
|
| Name |
National Institute of Siddha |
| Address |
Room no 7/8,Department of Maruthuvam,National Institute of siddha,Tambaram Sanatorium,Chennai-47. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Abirami S |
National institute of Siddha |
Room no7/8, Department of Maruthuvam,National Institute of Siddha,Tambaram Sanatorium,Chennai-47. Chennai TAMIL NADU |
9597350346
abiramisammu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K603||Anal fistula, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Gowri Chinthamani Chendooram(Internal) and Pachai ennai(External) |
200 mg of Gowri Chinthamani Chendooram along with adjuvant~1.5 g(Kattukarunakilangu podi+Kadukkai podi+Sukku podi+Thippili podi)with honey Bd,after food for 48 days.
Pachai ennai will be applied as Thiri.Thiri will be replaced 3 days once. |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
60.00 Day(s) |
| Gender |
Both |
| Details |
Participants having the clinical features of the following
Pain and swelling in the perianal region
Pus or blood discharge from perianal and anal region
Skin irritation
Perianal abscess
Fistula tract length less than 5 cm.
According to St James University Hospital Classification of Perianal Fistula,Grade I and Grade II.
Participants willing to undergo Kaarathiri therapy.
Participants already presenting with MRI Fistulogram or willing to undergo the MRI
from recognized laboratory. |
|
| ExclusionCriteria |
| Details |
Infectious risk category [Tuberculosis (Genitourinary tract),Hepatitis B & C,AIDS,Syphilis]
Hemophilia and bleeding disorders.
Pregnancy and lactation.
High anal fistula and Complicated fistula. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Outcome will be assessed by Peri-anal Disease Activity Index(PDAI) and good outcome of PDAI score becoming zero[Timepoints:Baseline and Post treatment (Day 48)] |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Outcome will be assessed by Unit Cutting time,
Unit cutting time=Total no f days taken for cut through/Initial length of the tract in cms=-----days/cms[Baseline and Post treatment (Day48)] |
18 months |
|
|
Target Sample Size
|
Total Sample Size="20" Sample Size from India="20"
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 2 |
|
Date of First Enrollment (India)
|
08/04/2025 |
| 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 Applicable |
| 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
|
BACKGROUND: Siddha system is one of the ancient systems of medicine, which originated from south India. According to Siddha medicine, diseases were classified into 4448 types based on Mukkutram (Vadham, Pitham, Kabam). Siddha system has a vast Internal and External medicines which cure the diseases. Most of the medicines are aimed at maintaining and balancing three humours (Vadham, Pitham, Kabam). In Yugi Vaithiya chinthamani, yugi classified the Powthiram disease into 8 types. Powthiram is characterized as a sinus present inside or outside anus or urethra. .The risk factors of powthiram in siddha literatures are, prolonged sitting, consuming spicy foods, horse mount, elephant climb, foods which cause piles. The common symptoms are redness, itching, and pain around the anus region, bloody or pus discharge from the fistula tract. According to Park’s classification it is classified into 4 types (Inter-sphincteric, Trans-sphincteric, Supra-sphincteric, Extra-sphincteric). The prevalence is greater in men than women, with a rate of 12.3 cases per 1,00,000 and 5.6 cases per 1,00,000 respectively. The average age at diagnosis is 38 years, with most occurring between 20 to 40 years of age.The goals in the treatment of an anal fistula are to eliminate the primary fistula opening, any associated tracts, or any secondary openings without change in incontinence. The simplest anal fistula are treated using fistulotomy with a recurrences and the other morbidities.Complex fistula management poses increased risk of a change in incontinence and the higher chances of recurrences which forced surgeons to search for a better option.Various modalities like cutting seton, Endorectal advancement flap, fibrin glue injection, fistula plug, Ligation of intersphincteric Fistula Tract (LIFT) are being tried to overcome the hardship faced by the patients. Siddha system of medicine treats the disease in more cost effective and palatable way, when compared with modern medicine. The formulation selected for this dissertation study is Gowri chinthamani chendooram (internal), which is described in Agasthiyar vaithiya kaviyam- 1500 and Pachai ennai (external) which is described in The pharmacopoeia of Siddha research medicines for Powthiram (fistula- in- ano).So, I have chosen this medicine for management of Powthiram. Kaarathiri is the best procedure for treatment of chronic ulcers, abscess and fistula-in-ano.Thiri will be prepared by applying Pachai ennai to sterilised gauze. OBJECTIVES: Primary objective:To determine the effectiveness of Gowri chinthamani chendooram (Internal) and Pachai ennai (External) in the management of Powthiram through Perianal Disease Activity Index (PDAI) score. Secondary objective: To measure the unit cutting time assessed by, Unit cutting time = total number of days taken for cut through / Initial length of track in cms = ------days / cm. STUDY DESIGN: This is an interventional study of Non Randomized sampling which will be carried out for 18 months in participants with Fistula-in-Ano reporting to OPD of Ayothidoss Pandithar Hospital, National Institute of Siddha,Chennai-47 with 20 Participants as Sample size.Participants with age from 18 to 60 years of both age and with Fistula-in-ano will be included. OUTCOME OF THE STUDY: Primary outcome will be assessed by Peri-anal Disease Activity Index (PDAI) and good outcome of PDAI score becoming zero, [Time points: baseline and post-treatment (Day 48)] Outcome will be assessed by unit cutting time, Unit cutting time = total no of days taken for cut through / initial length of the tract in cms = -----days / cm [Time points: baseline and post-treatment (Day 48)]. RESULTS AND DISCUSSION: The results will be statistically analysed and reported. KEYWORDS: Powthiram, Gowri Chinthamani Chendooram, Pachai ennai, Fistula-in-Ano. |