Clinical trial to evaluate the combined efficacy of Zandu Kutaja Ghana Vati and Zandu Mugdha Rasa in the management of Atisara(Functional Diarrheoa)

An open label double arm randomized controlled comparative Clinical Trial to evaluate the safety & effectiveness of Zandu Kutaja Ghana Vati in comparison to Zandu Kutaja Ghana Vati along with Zandu Mugdha Rasa in the management of Atisara - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/12/078288

Enrollment

Registered

2024-12-18

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: K928- Other specified diseases of the digestive system

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Clinical presentation of Functional Diarrheoa symptoms Patients with Atisara lakshana Patients with either sex, 18 to 60 years age All patients must agree not to share medication Patients willing to participate and sign an informed consent Understands and agrees to comply with planned study procedures Agrees to provide sample for testing as per protocol

Exclusion criteria

Exclusion criteria: Chronic, Severe, Unstable, Uncontrolled co-existent Medical illness such as Diabetes, Hypertension, Cardiac disorders, liver, kidney disorders and lung Disorders or other disease of concern which may put the patient at increased risk during the study Active cancer diagnosis, on palliative treatment or requiring current therapy with antimetabolic agents, immunotherapy or radiotherapy. Patients on parenteral nutrition Patients with known sensitivity or contraindication to any of the ingredients of study medication History of bleeding haemorrhoids, haemoptysis, acid peptic diseases, ulcers and pulmonary diseases (tuberculosis, asthma, etc.) Pregnancy and lactation Participation in a drug interventional clinical drug trial of any nature in the three month period Patients who are either on Allopathy medicines or on other AYUSH medications

Design outcomes

Primary

Measure	Time frame
Trial drug Zandu Mugdha Rasa 1 tablet and Zandu Kutaja Ghana Vati 2 tablets twice daily regularly after meals along with luke warm water may be effective in managing the symptoms as per Rome IV Criteria for Functional Diarrheoa and significant changes may be noted in parameters like LFT, RFT andLipid profileTimepoint: Day 1 and Day 7	—

Secondary

Measure	Time frame
The Trial drug is effective in managing symptoms of Functional Diarrhea with respect to laboratory parametersTimepoint: Day 1 and Day 7	—

Countries

India

Contacts

Public ContactDr Sumit Srivastava

Shri Dhanwantry Ayurvedic College and Hospital, Sector 46-B, Chandigarh

sumitpankaj@gmail.com09781110780

Outcome results