A Single Arm Phase II Clinical Study To Evaluate The Effectiveness Of Siddha Formulation SEENTHIL CHOORNAM In The Treatment of NEERCHURUKKU (Urinary Tract Infection) Among Outpatients Attending Ayothidoss Pandithar Hospital, National Institute of Siddha.

Background:

The siddha system is based on a combination of ancient medicinal practices and spiritual disciplines as well as alchemy and mysticism. Yugi classified diseases based on signs and symptoms. In his text book of Yugi vaithiya chinthamani, he classified neerchurukku into four types. One among them is Azhal Neerchurukku. Its signs and symptoms may be correlated with the Urinary Tract Infection in modern medicine.The characteristic features of Azhal Neerchurukku is Urine that may appear cloudy, dark and concentrated, oliguria, Suprapubic pain and pain in the urethra during and after voiding , Abrupt onset of frequency of micturation and urgency.

Urinary tract infections are the most common bacterial infections and affect one million people globally each year. Among nosocomial infections, Urinary tract infections are second only to lower respiratory tract infections, which represent twenty four percentage of such cases in developing countries. The symptoms of urinary tract infections are variable, ranging from no symptoms to a severely unwell patient with a high temperature and, sometimes, secondary bacteremia. Urinary tract infections can be divided into three catogories: acute pyelonephritis, acute cystitis, and asymptomatic bacteriuria. Clinically, Urinary tract infections is categorized as uncomplicated or complicated. Uncomplicated Urinary tract infections typically affect individuals who are otherwise healthy and have no structural or neurological urinary tract abnormalities. These infections are differentiated into lower urinary tract infections  and upper urinary tract infections . Urinary tract infections are caused by both Gram-negative and Gram-positive bacteria, as well as by certain fungi. The most common causative agent for both uncomplicated and complicated Urinary tract infections is uropathogenic Escherichia coli .

Objective:

Primary objective:

To determine the clinical effectiveness of the Siddha formulation Seenthil choornam in the management of Neerchurukku through urine culture.

Secondary objective:

The reduction in clinical signs and symptoms is assessed by urinary tract infection symptom assessment score UTISA questionarre.

Study design:

Study type:An experimental study

Study design :Single arm Phase II clinical study

Study place:Maruthuvam OPD of Ayothidoss Pandithar Hospital, National Institute of Siddha, Tambaram Sanatorium,Chennai.

Study period:Eighteen Months

Sample size:Thirty

Inclusion criteria:

Age: Eighteen to Sixty years.

Gender: All

Participants with positive urine culture at the beginning of screening.

Participants with urine pus cells more than six will be subjected to urine culture.

Uncomplicated urinary tract infections -known relevant functional or anatomical urological abnormalities.

Exclusion criteria:

Complicated Urinary tract infections - Patients with relevant anatomical or functional abnormalities of the urinary tract, indwelling urinary catheters or with altered defences.

Known case of Renal CA

Known case of Renal Calculus

Known case of Medical Renal Disease

Known case of Genitourinary tuberculosis

Known case of Sexually transmitted diseases

Outcome:

Primary Outcome:

Primary Outcome is assessed by reduction in colonies count and negative report of urine culture test after a week of treatment.

Secondary Outcome:

Reduction in clinical signs and symptoms which can be assessed by Urinary tract infections Symptom assessment score as follows,

If the score is less than or equal to twenty one then it is severe.

If the score is less than or equal to fourteen then it is moderate .

If the symptom score becomes less than seven then it is considered as good improvement.

Results and discussion: The results will be statistically analyzed and reported.

Keywords: Neerchurukku, Urinary tract infection, Seenthil choornam.