Pun sudar thyla thiri for Pouthiram (Fistula in ano)

Phase 3

Completed

Brief Summary: It is an an open single arm single centric clinical trial to determine the therapeutic effectiveness of *Pun sudar thyla thiri* in the management of *Pouthiram* (Fistula in Ano). The clinical signs and symptoms are recurrent anal abscess, pain and swelling around the anus, pain with bowel movements, bloody or foul smelling, pus/blood discharge from opening around the anus will be enrolled based on the inclusion and exclusion criteria. After enrolling the patients in the study, the treament will be given for 3 months 2 days once. After 3 months the reduction in symptoms will be assessed by Perianal Disease Activity Index (PDAI).

Recruitment & Eligibility

Inclusion Criteria

1.Age: 18 to 60 years.
2.Patients having the clinical features of the following Pain and swelling in the perianal region Pus and or blood discharge from perianal and anal region.
Skin irritation.
Perianal abscess.
3.Sex: Male, Female and Transgender.
4.Fistula tract length within 4 cm.
5.According to St James University Hospital Classification, Grade I and II will be included.
6.Patient who are willing to undergo Kaarathiri therapy.
7.Willing to give specimen of blood for investigation whenever required.
8.Willing to attend OPD or admission in IPD if necessary.

Exclusion Criteria

1.K/c/o Tuberculosis 2.K/c/o Hepatitis B & C.
3.K/c/o Haemophilia and bleeding disorders.
4.H/o Pregnancy & Lactation.
5.The patient who has uncontrolled diabetes (HbA1C more than 7.6) will be treated for diabetes and after the confirmation of good control he/she will be included for this study.
6.K/c/o coronary heart diseases and other cardiac ailments.
7.K/c/o AIDS, Syphilis.
8.K/c/o Crohnâ€™s disease.
9.K/c/o High anal fistula and complicated fistula 10.K/c/o Rectal prolapse 11.K/c/o Rectal carcinoma.

Primary Outcome Measures

Name	Time	Method
The outcome of the study will be measured by Reduction in pain, pus discharge, burning sensation, itching around the anus well be accessed by Perianal Disease Activity Index Score (PDAI).	3 MONTHS

Secondary Outcome Measures

Name	Time	Method

Locations (1): Ayothidoss Pandithar Hospital National Institute of Siddha Tambaram sanatorium Chennai 600 047.
🇮🇳
Kancheepuram, TAMIL NADU, India
Ayothidoss Pandithar Hospital National Institute of Siddha Tambaram sanatorium Chennai 600 047.
🇮🇳Kancheepuram, TAMIL NADU, India
Dr SANJANA S
Principal investigator
7904237083
sanjanateddy16@gmail.com