Skip to content

Clinical Trial to evaluate the effectiveness of Siddha formulations in the management of Kalleeral Noi(Alcoholic Liver Disease) among Out Patients attending Ayothidoss Pandithar Hospital

An Open Label Single Arm Clinical Trial to evaluate the effectiveness of Siddha formulations in the management of Kalleeral Noi(Alcoholic Liver Disease) among Out Patients attending Ayothidoss Pandithar Hospital - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/02/081092
Enrollment
30
Registered
2025-02-21
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

Health Condition 1: K70- Alcoholic liver disease

Interventions

Intervention1: Thaalisathi Chooranam & Vediannabethi Chenduram: Internal Medicines : 1.Thaalisathi Chooranam - 2 gm, bd, after food with Honey. 2.Vediannabethi Chenduram - 130 mg, bd, after food with

Sponsors

National Institute of Siddha
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: History of Alcoholic Abuse for more than five years and the Alcoholic dependency will be confirmed by AUDIT questionnaire Subjects who are willing to quit Alcohol Participants with clinical signs and symptoms of early stages of Alcoholic Liver Disease that confirmed with USG. Individuals with elevated Liver enzymes Total bilirubin Direct and Indirect Bilirubin levels such as AST,ALT,ALP, GGT and lipid profile Patients with an MDF score of less than 32

Exclusion criteria

Exclusion criteria: Individuals with advanced stages of Alcoholic liver disease with MELD score of greater than 20 Withdrawal symptoms like seizure , Alcohol Withdrawal Delirium and Alcohol Hallucinosis Substance abuse other than alcohol like Narcotics Pregnant and Lactating women participants with known liver diseases such as inherited metabolic causes Hemochromatosis Wilsons disease Hepatic infection and hepatic carcinoma

Design outcomes

Primary

MeasureTime frame
The Therapeutic effectiveness of Siddha formulations will be evaluated by observing improvement in clinical signs and symptoms after treatment.Timepoint: Screening Period: 2 Months Trial period: 14 months Assessment Period:2 Months.

Secondary

MeasureTime frame
Monitoring the changes in the MDF score & MELD SCORE, Lab parameters including LFT (Serum Bilirubin, AST, ALT, ALP, GGT), & lipid profile with its permissible limit after treatment. Observing the changes in hematological, liver, & renal functional markers will ensure the safety of the trial drugs.Timepoint: Screening period: 2 months Trial period: 14 months Assessment period:2 months

Countries

India

Contacts

Public ContactDr. S. Murugesan

National Institute of Siddha

ss.drss@gmail.com9841108269

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026