| CTRI Number |
CTRI/2025/06/088418 [Registered on: 06/06/2025] Trial Registered Prospectively |
| Last Modified On: |
29/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Research on Taurine and L-Carnitine supplements for relief of muscle cramps in patients with liver cirrhosis
|
|
Scientific Title of Study
|
A double-blind Randomized control trial to study the efficacy of combination of Taurine and L-Carnitine in alleviating muscle cramps in patients with liver cirrhosis. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aabha Nagral |
| Designation |
Consultant Gastroenterology |
| Affiliation |
Jaslok Hospital and Research Centre |
| Address |
Department of Gastroenterology Jaslok Hospital and Research Centre
15 Pedder Rd IT Colony Tardeo
Mumbai
Mumbai
MAHARASHTRA
400026
India |
| Phone |
9820156834 |
| Fax |
|
| Email |
aabhanagral@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aabha Nagral |
| Designation |
Consultant Gastroenterology |
| Affiliation |
Jaslok Hospital and Research Centre |
| Address |
Department of Gastroenterology Jaslok Hospital and Research Centre
15 Pedder Rd IT Colony Tardeo
Mumbai
MAHARASHTRA
400026
India |
| Phone |
9820156834 |
| Fax |
|
| Email |
aabhanagral@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sukhada Thorat |
| Designation |
clinical coordinator |
| Affiliation |
Jaslok Hospital and Research Centre |
| Address |
Department of Gastroenterology Jaslok Hospital and Research Centre
15 Pedder Rd IT Colony Tardeo
Mumbai
Mumbai
MAHARASHTRA
400026
India |
| Phone |
9422352635 |
| Fax |
|
| Email |
thorat.sukhada1978@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saimirra Innopharm Pvt Ltd
288 & 299 SIDCO Estate, Ambattur,
Chennai-600098
Tamil nadu
India |
|
|
Primary Sponsor
|
| Name |
Saimirra Innopharm Pvt ltd |
| Address |
Telephone exchange shed.288 and 299
SIDCO Estate
Ambatur
Chennai 600098
Tamil Nadu
India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Aabhanagral |
Jaslok Hospital and Research Centre |
Department of Gastroenterology Jaslok Hospital and Research Centre
15 Pedder Rd IT Colony Tardeo
Mumbai
Mumbai
MAHARASHTRA |
09820156834
aabhanagral@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Jaslok Hospital and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K745||Biliary cirrhosis, unspecified, (2) ICD-10 Condition: K746||Other and unspecified cirrhosis ofliver, (3) ICD-10 Condition: K743||Primary biliary cirrhosis, (4) ICD-10 Condition: K744||Secondary biliary cirrhosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
Each 535mg Placebo contains Mannitol 290mg, Sucralose 100mg, Butylated Hydroxyanisole 25mg, Butylated hydroxy toluene 5mg, Colloidal anhydrous silica 75mg and Capsil orange flavor 50mg |
| Intervention |
Taurine and L-Carnitine |
Each sachet contains 3g Taurine and 1.465 g L-Carnitine Tartrate equivalent to 1g L-Carnitine |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Cirrhotic patients with muscle cramps frequency more than or equal to 3 times a week at rest or during sleep.
Willing to provide informed consent and comply with study procedures.
|
|
| ExclusionCriteria |
| Details |
Patients with known allergies to taurine or L-carnitine.
No alcohol or IV drug use for the last 3 months.
Blood glucose level more than 270mg/dl at the time of enrolment.
Patients currently taking muscle relaxants or other supplements that might interfere with the study results.
Pregnant or breastfeeding women.
Patients with CKD.
Patients with uncontrolled hepatic encephalopathy
History of Peripheral neuropathy, Thyroid disease, Pulmonary hypertension, Cardiac disease
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The objective of this study is to evaluate the efficacy of L-Carnitine and Taurine supplementation in reducing the frequency, severity, and duration of muscle cramps in patients with liver cirrhosis. |
Each patient from each of the 3 groups shall be followed up a total of 3 times:
At 1st month: Via video consultation
At 2nd month: Via video consultation
At 3rd month: By physical consultation in OPD
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
09/06/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a double-blind, randomized, placebo-controlled clinical trial designed to evaluate the efficacy of a combination of L-Carnitine (1g) and Taurine (3g) in alleviating muscle cramps in patients with liver cirrhosis. Muscle cramps are a common yet often overlooked complication in liver cirrhosis, significantly impacting patients’ quality of life. Objectives: Primary Objective: To assess the effectiveness of L-Carnitine and Taurine in reducing the frequency, severity, and duration of muscle cramps in cirrhotic patients.Study Design:Population: 70 participants (35 in each group) aged 18–75 years with liver cirrhosis and experiencing at least 3 muscle cramps per week.Randomization: Participants will be randomly assigned to two groups:Group A: Receives L-Carnitine and Taurine combination as a sachet mixed with water daily for 3 months.Group B: Receives a placebo sachet daily for 3 months.Blinding: Double-blind design, ensuring both participants and investigators are unaware of group assignments.Key Measurements:Participants will maintain a symptom diary to record the frequency and duration of muscle cramps.The severity of cramps will be assessed using the Visual Analogue Scale (VAS).Follow-ups will be conducted monthly (via video and in-person consultations).Inclusion and Exclusion Criteria:Inclusion: Adults with liver cirrhosis experiencing frequent muscle cramps and willing to comply with study procedures.Exclusion: Patients with allergies to the study drugs, alcohol use in the past 3 months, or conditions like uncontrolled hepatic encephalopathy or chronic kidney disease.Expected Outcomes:This trial aims to demonstrate that the combination of L-Carnitine and Taurine is effective and safe for reducing muscle cramps in cirrhotic patients, potentially improving their overall well-being and quality of life. |