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Ursodeoxycholic Acid

A Real-World Evidence Study to Evaluating the Safety and Effectiveness of Ursodeoxycholic Acid at various clinics across India.

BASIC DETAILS

Date *

Patient Initials*

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Patient ID*

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Eligibility of the subjects

Please tick (✔) as applicable
		Yes	No
1	Male or female subjects within the age group 18 or above
2	Subject Diagnosed with Diagnosed with primary biliary cholangitis (PBC), primary sclerosing cholangitis (PSC), or other conditions for which Ursodeoxycholic Acid is prescribed.
3	Prescribed Ursodeoxycholic Acid as part of routine clinical care.
4	Available clinical records and follow-up data.

Demographic data

Gender*

Male Female

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Subject Initial *

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Age *

Height (cm) *

Weight (kg) *

Comorbidities *

Digestive diseases Autoimmune diseases Hyper tension Anemia Cardiovascular diseases Chronic kidney disease mental disorders Others

Diagnosis and treatment details

Primary diagnosis *

Primary Biliary Cholangitis Primary Sclerosing Cholangitis

Other Relevant Diagnoses

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Date of First Prescription *

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Indication for Ursodeoxycholic Acid *

Initial Dose & frequency: *

Duration of treatment *

Start month

End month

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Current Dose *

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Baseline symptoms (Before use of Ursodeoxycholic Acid)

Jaundice Severity *

Mild Moderate Severe

Pruritus (Itching) *

Yes No

Abdominal pain Severity *

Mild Moderate Severe

Other Symptoms

Post treatment symptoms

Jaundice Severity *

Mild Moderate Severe

Pruritus (Itching) *

Yes No

Abdominal pain Severity *

Mild Moderate Severe

Other Symptoms

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Follow up period *

Start date

End date

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Laboratory Tests

	ALT	AST	ALP	Bilirubin Levels
Baseline Liver Function Tests
Follow-Up Liver Function Tests

Patient-Reported Outcomes

Quality of life assessment (If applicable)
Instrument Used
Baseline Score
Follow-Up Score

Symptom Relief

Jaundice Relief *

Improved No change Worsened

Pruritus (Itching) *

Improved No change Worsened

Abdominal pain Relief *

Improved No change Worsened

Other Symptoms Relief

Overall Satisfaction with Treatment

Rating *

Very Satisfied Satisfied Neutral

Comments if any (Additional patient comments)

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