| CTRI Number |
CTRI/2013/12/004203 [Registered on: 10/12/2013] Trial Registered Retrospectively |
| Last Modified On: |
22/08/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
CLINICAL RESEARCH ON TRADITIONAL SIDDHA MEDICINE IN KALLADAIPPU (KIDNEY STONE)PATIENTS. |
|
Scientific Title of Study
|
Evaluation of safety and efficacy of NANDUKKAL PARPAM in the treatment of KALLADAIPPU (UROLITHIASIS) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIS/PPHD/11/0105 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR H NALINI SOFIA |
| Designation |
LECTURER |
| Affiliation |
NATIONAL INSTITUTE OF SIDDHA |
| Address |
DEPARTMENT OF MARUTHUVAM(MEDICINE)
NATIONAL INSTITUTE OF SIDDHA,
TAMBARAM SANATORIUM,
CHENNAI
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9677777677 |
| Fax |
044-22381314 |
| Email |
dr.h.nalinisofia@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PROF DR K MANICKAVASAKAM |
| Designation |
DIRECTOR |
| Affiliation |
NATIONAL INSTITUTE OF SIDDHA |
| Address |
NATIONAL INSTITUTE OF SIDDHA,
TAMBARAM SANATORIUM,
CHENNAI
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9444979034 |
| Fax |
044-22381314 |
| Email |
dr.kmvm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR THOMAS M WALTER |
| Designation |
LECTURER(Selection grade) |
| Affiliation |
GOVT.SIDDHA MEDICAL COLLEGE HOSPITAL |
| Address |
DEPARTMENT OF GUNAPADAM(PHARMACOLOGY)
GOVT.SIDDHA MEDICAL COLLEGE HOSPITAL
PALAYAMKOTTAI
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443378798 |
| Fax |
0462-2572736 |
| Email |
dr.thomaswalter@gmail.com |
|
|
Source of Monetary or Material Support
|
| AYOTHIDOSS PANDITHAR HOSPITAL
NATIONAL INSTITUTE OF SIDDHA
TAMBARAM SANATORIUM |
|
|
Primary Sponsor
|
| Name |
AYOTHIDOSS PANDITHAR HOSPITAL |
| Address |
AYOTHIDOSS PANDITHAR HOSPITAL
NATIONAL INSTITUTE OF SIDDHA
TAMBARAM SANATORIUM
CHENNAI
TAMIL NADU
INDIA |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DRHNALINI SOFIA |
AYOTHIDOSS PANDITHAR HOSPITAL |
AYOTHIDOSS PANDITHAR HOSPITAL
OPD.NO.1, DEPT.OF MARUTHUVAM
NATIONAL INSTITUTE OF SIDDHA
TAMBARAM SANATORIUM
Kancheepuram
TAMIL NADU |
9677777677
044-22381314
dr.h.nalinisofia@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
KALLADAIPPU(KIDNEY STONE), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nandukkal parpam |
260 mg of Nandukkal parpam will be administered along with 50 ml sirupeelai kudineer twice a day for a period of 60 days. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
• Age between 20 and 60 years
• Both male and female patients
• Classical pain is described as pain from loin to groin, accompanied by nausea, vomiting and gaseous distension.
• Pain and or burning while passing urine.
• Patient with renal calculus detected on X-ray KUB or USG abdomen
• History of Recurrence of renal stone
• Stone size 5mm & > 5mm to < 10mm
• Urine routine which will show Crystals in urine.
• Patients are willing and able to give informed consent for participation in the study.
• Ability to understand study procedures and to comply with them for the entire length of the study.
|
|
| ExclusionCriteria |
| Details |
• Stone size > 10 mm
• Obstruction requiring immediate surgery (Marked hydronephrosis)
• Pregnancy and Lactation
• women with childbearing potential without adequate contraception
• Use of disallowed concomitant medications (NSAID)
• Patient taking any other lithotriptic agent
• History of Diabetes/ Hypertension
• History of hepatic/ renal/ cardiac disease
• History of taking treatment for any other ailments.
• History of drug/alcohol abuse
o Experiencing habitual alcohol-related legal problems.
o Repeated drinking despite ongoing alcohol-related relationship problems.
o Failure to attend to important responsibilities at work, school or college, or home.
• Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
• Treatment with another investigational drug or other intervention (within a period of 30 days)
• Participated in any research study within the past six months.
• Donated blood within the past six months.
• Any psychiatric condition that could prevent patient from signing the informed consent or could put the patient at an unacceptable risk in case of participating in the trial
• Medical condition, laboratory finding, or physical exam finding (e.g., vital signs outside of specific range) that precludes participation.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| STONE EXPULSION,REDUCTION IN STONE SIZE |
AFTER 60 DAYS OF TREATMENT |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| RENAL FUNCTION -UREA,CREATININE,URIC ACID LEVEL |
PRE STUDY SCREENING AND AFTER 60 DAYS OF TREATMENT |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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 3 |
|
Date of First Enrollment (India)
|
18/11/2013 |
| 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="1"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
It is a single, non-randomized, open-label trial to determine the efficacy and safety of NANDUKKAL PARPAM in patients with KALLADAIPPU (UROLITHIASIS). The trial drug Nandukall parpam is a sidhha medicine (Traditional Indian system of Medicine) developed from marine product named as fossil stone crab (Nandukkal).In this trial 110 kidney stone patients will be recruited and the trial drug will be administered 260 mg twice a day along with sirupeelai kudineer (a decoction made from whole plant of Aerva lanata) for a period of 60 days. During this trial period all the study related data will be recorded and documented in a separate trial master file for each patients. During the trial period if any AE/SAE/SUSAR will be noticed and referred to pharmacovigilance dept.in NIS and further management will also be given in NIS OPD/IPD. The entire trial will be monitored by the research monitoring committee OF NIS. During this trial all the safety and efficacy parameters will be recorded in the CRF. After completion of the trial all the study related data will be analysed statistically . The out come of this trial will be published in Indian Journal of Medical Research. |