Clinical evaluation of siddha formulation Koozhpaanda chooranam (internal) and Powthira Ranangalukku kalimbu (external) in the management of Paganthara moolam (fistula in ano)

Phase 2

Not yet recruiting

Conditions: Anorectal fistula. Ayurveda Condition: nil, (2) ICD-10 Condition: K928||Other specified diseases of the digestive system,

Registration Number: CTRI/2022/10/046913

Lead Sponsor: National institute of Siddha

Brief Summary: This is an open non-Randomised clinical trial that evaluates therapeutic effectiveness of siddha formulation KOOZHPAANDA CHOORANAM(INTERNAL) and POWTHIRA RANANGALUKKU KAZHIMBU (EXTERNAL) in the management of PAGANTHARA MOOLAM (FISTULA- IN ANO) patients throughMRI- Fistulogram) beforetreatment and Perianal Disease Activity Index(PDAI) before and aftertreatment.Fistula in-ano is the second most prevalent anorectal disorder afterhemorrhoids. According to Parkâ€™s classification it classified into 4 types(Inter-sphincteric, Trans-sphincteric, Supra-sphincteric, Extra-sphincteric).The causes for fistula in ano are cryptoglandular (90%), non-cryptoglandular(10%). The cryptoglandular infection in anal region that causes abscess and pusand mucous discharge draining from external opening through fistula track. Thesymptoms are recurrent anal abscess, pain and swelling around anal region,bloody or foul- smell drainage (pus) from an opening around the anus, pain withbowel movement. So, my aim is totreat the Paganthara Moolam (fistula- in ano) with the Siddha formulation *KOOZHPAANDACHOORANAM (INTERNAL) and POWTHIRA RANANGALUKKU KAZHIMBU (EXTERNAL)*.

MATERIALS AND METHODS:A Total of 20 diagnosedpatients of Paganthara moolam (fistula- in ano) within the age limit of 20 -60years willing to participate in the study,by signing the consent form will be enrolled in the study. Tuberculosis (Genitourinary tract), Hepatitis B & C, Hemophilia and bleeding disorder,Pregnancy & Lactation, Uncontrolled Diabetes, Coronary Heart Disease, AIDS& Syphilis, Crohnâ€™s disease, High anal fistula and complicated fistula,Rectal prolapse, Rectal carcinoma will be excluded. Assessment in improvement is done throughPerianal Disease Activity Index (PDAI) before and aftertreatment.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 20

Inclusion Criteria

1.Age: 20 to 60 years 2.Pus, blood and watery discharge from perianal and anal region 3.Sex: Male, Female and Transgender 4.Fistula tract within 4 cm 5.Patient who are willing to undergo kaaraseelai therapy 6.Willing to give specimen of blood for investigation whenever required 7.Willing to attend OPD or admission in IPD 8.Willing to take photograph before and after treatment 9.Patient already presenting with MRI fistulogram or willing to get the MRI from recognized laboratory.

Exclusion Criteria

1.Tuberculosis (Genito urinary tract).
2.Hepatitis B & C.
4.Pregnancy & Lactation.
5.Uncontrolled diabetes.
6.K/H/O Cardio vascular Diseases.
7.AIDS, Syphilis.
8.K/H/O Crohnâ€™s disease.
9.High anal fistula and complicated fistula.
10.Rectal prolapse.
11.K/H/O Rectal carcinoma.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The measurement of the tract length before and after treatment will be assessed by PDAI and good outcome of PDAI score becoming zero.	1 year

Secondary Outcome Measures

Name	Time	Method
secondary outcome is assessed by unit cutting time	1 year

Trial Locations

Locations (1): Ayothidoss pandithar hospital
🇮🇳
Kancheepuram, TAMIL NADU, India
Ayothidoss pandithar hospital
🇮🇳Kancheepuram, TAMIL NADU, India
DrR MOHANA
Principal investigator
8508439127
rmohana796@gmail.com