Efficacy of Zandu Nityam tablet and Zandu Nityam churna

Evaluation of the safety & efficacy of Zandu Nityam Tablet incomparison to Zandu Nityam Churna in the management of Malavrodha w.s.r.t. Functional Constipation : A RCT - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/01/079006

Enrollment

Registered

2025-01-20

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K590- Constipation

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Patients of Functional constipation, fulfilling diagnostic criteria of ROME III criteria for functional constipation, Patients irrespective of sex, caste and religion, patients willing to provide informed consent

Exclusion criteria

Exclusion criteria: Patients not fulfilling the diagnostic criteria. Pregnant and lactating women Patients of other gastro-intestinal diseases like IBS etc. patients having life threatening disorders like malignancies, renal failure, cardiac failure. patients having other co-morbidities like hypertension, diabetes mellitus, hypothyroidism etc.

Design outcomes

Primary

Measure	Time frame
1.Zandu Nityam Tablet is non-inferior to Zandu Nityam Churna in improving bowel movement frequency and stool consistency 2. Zandu Nityam Tablet has a comparable safety profile to Zandu Nityam ChurnaTimepoint: 6 months Period required for pre-trial preparation: 45 Period which may be needed for collecting the data: 3 months period that may be required for analyzing the data: 1 month period that may be required for submitting final report: 15 days	—

Measure

Time frame

1.Zandu Nityam Tablet is non-inferior to Zandu Nityam Churna in improving bowel movement frequency and stool consistency 2. Zandu Nityam Tablet has a comparable safety profile to Zandu Nityam ChurnaTimepoint: 6 months Period required for pre-trial preparation: 45 Period which may be needed for collecting the data: 3 months period that may be required for analyzing the data: 1 month period that may be required for submitting final report: 15 days

—

Secondary

Measure	Time frame
Assessment of patient satisfaction with the treatment, including ease of use, preference for tablets vs. churna, and perceived effectiveness.Timepoint: 6 months Period required for pre-trial preparation: 45 Period which may be needed for collecting the data: 3 months period that may be required for analyzing the data: 1 month period that may be required for submitting final report: 15 days	—

Countries

India

Contacts

Public ContactVaidya Kanika Aggarwal

Shri Dhanwantry Ayurvedic college and hospital, chandigarh

sumitpankaj@gmail.com7986502791

Outcome results