A single group pre and post designed clinical study to determine the effectiveness of Calcirex capsule in the patients of urinary stone.

Participants (patients) who fulfill the inclusion criteria will be selected from the outpatient and in-patient department of P D Patel Ayurved Hospital attached with J S Ayurved Mahavidyalaya after taking their consent.

Diagnostic procedure: Patients having one or more of the signs and symptoms of urinary stone i.e. pain in abdomen or loin, increased frequency of urine, burning micturition, hematuria and nausea or vomiting will be examined and screened for urine routine and microscopic exam. Presence of crystals, casts, RBC, epithelial cells in urine will be noted. However, confirmation of diagnosis will be on the base of ultrasound scan reports suggesting the presence of stone in urinary tract.

Intervention and dosage of drugs: Calcirex capsule will be an intervention of the study. Each capsule is of 500 mg which contains following ingredients.

Extract of Bergenia ciliate (rhizome of Pashanabheda) - 100 mg

Extract of Crataeva nurvala (stembark of Varuna) - 100 mg

Extract of Boerhavia diffusa (root of Punarnava) - 60 mg

Extract of Tribulus terrestris (fruit of Gokshura) - 60 mg

Hazaul Yahud pishti (Lapis Juidaicus) -100 mg

Shuddha Shilajit (Asphaltum punja- bianum) - 50 mg

Hordeum vulgare (Sarjikakshara) - 30 mg

Two capsules of Calcirex will be given three times in a day with warm water and after the meal.

Diet for all the patients: Mung, mung beans soup, rice, gram flour chapati, vegetables which are easy to digest will be recommended to the patients. Sour tasty, fermented food items and vegetables which contain small seeds i.e. tomatoes, chilies, lady finger will not be allowed.

Duration of treatment: Main assessment period will be after the 4 weeks of the treatment. During the follow-up period, patients will be instructed to continue all the oral medicaments and diet as per the mentioned schedule.

Assessment of patients: Patients will be assessed on the basis of relief in signsymptoms, other invasive investigation and findings of laboratory on the basis of specially designed research Performa through scoring pattern.

Outcome measures: Assessment of therapy was done according to the relief observed in the sign and symptoms with the help of following scoring pattern.

The details of the scores adopted for the chief signs and symptoms (before and after treatment) in the present study are as follows –

1. Pain

No pain - 0

Bearable pain (1 or 2 times during study period) - 1

Bearable pain occasionally (average 2 to 3 times /week) - 2

Bearable pain Everyday – 3

2. Burning micturition

No burning micturition – 0

Burning micturition (1 or 2 times during study period) - 1

Regular burning micturition (average 2 to 3 times /week) - 2

Regular burning micturition everyday - 3

3. Haematuria

No haematuria - 0

Smoky black coloured urine - 1

Bright red coloured urine – 2

4. Frequency of micturition (in 24 hours)

Up to 6 times - 0

7-9 times - 1

10-12 times - 2

12 times – 3

5. Size of stone (with the help of USG)

6. Number of stones (with the help of USG)