| CTRI Number |
CTRI/2020/09/027900 [Registered on: 18/09/2020] Trial Registered Prospectively |
| Last Modified On: |
17/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A CLINICAL TRIAL TO STUDY THE EFFECT OF SIDDHA DRUG PAVALA VEERA CHUNNAM IN PATIENTS HAVING CHOLELITHIASIS |
|
Scientific Title of Study
|
PHASE II NON-RANDOMIZED OPEN CLINICAL EVALUATION OF SIDDHA MEDICINE PAVALA VEERA CHUNNAM FOR SATHTHI PITHAM (CHOLELITHIASIS) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nikil Niva J |
| Designation |
pg scholar |
| Affiliation |
Government Siddha Medical College Chennai |
| Address |
Department of General Medicine
Government Siddha Medical College
6 Anna Arch road
Nsk Nagar
arumbakkam
Chennai
Tamilnadu 600106
Chennai
TAMIL NADU
600106
India |
| Phone |
7200333774 |
| Fax |
|
| Email |
nikilniva@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sasirekha R |
| Designation |
Lecturer |
| Affiliation |
Government Siddha Medical College Chennai |
| Address |
Department of General Medicine
Government Siddha Medical College
6 Anna Arch road
Nsk Nagar
arumbakkam
Chennai
Tamilnadu 600106
Chennai
TAMIL NADU
600106
India |
| Phone |
9444832728 |
| Fax |
|
| Email |
sasirekha.siddha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nikil Niva j |
| Designation |
pg scholar |
| Affiliation |
Government Siddha Medical College Chennai |
| Address |
Department of General Medicine
Government Siddha Medical College
6 Anna Arch road
Nsk Nagar
arumbakkam
Chennai
Tamilnadu 600106
Chennai
TAMIL NADU
600106
India |
| Phone |
7200333774 |
| Fax |
|
| Email |
nikilniva@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Siddha Medical College
6 Anna Arch road
Nsk Nagar
arumbakkam
Chennai
Tamilnadu 600106 |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College Chennai |
| Address |
Government Siddha Medical College
6 Anna Arch road
Nsk Nagar
arumbakkam
Chennai
Tamilnadu 600106 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Dr Nikil Niva J |
Arignar Anna Government Hospital for Indian Medicine |
Room No 2
Siddha Department
Department of General Medicine
6 Anna Arch road
Nsk Nagar
arumbakkam
Chennai
Tamilnadu 600106
Chennai
TAMIL NADU |
07200333774
nikilniva@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 |
(1) ICD-10 Condition: K808||Other cholelithiasis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
Pavalaveera Chunnam
|
65mg of Pavalaveera Chunnam is Administrated twice a day with milk for 48 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Accidentally identified gall stone in USG
Asymptomatic Cholelithiasis.
Stone Size less than 8mm (normal lumen size is 8mm)
|
|
| ExclusionCriteria |
| Details |
Pregnant and lactating mothers.
Cholecystitis.
Pancreatitis
Obstructive Jaundice.
Choledo Cholelithiasis
Acute Cholelithiasis
Gall Stone patients with other comorbidities
Malignancy of gall bladder
-Will be excluded clinically or based on available medical reports
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Outcome is mainly assessed by reduction in clinical symptoms measured by reduction in size of gall stones with interpretation of USG abdomen. |
48days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 2 |
|
Date of First Enrollment (India)
|
21/09/2020 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is Phase II Non -Randomized open Clinical Trial to study the safety and efficacy of siddha drug PAVALAVEERA CHUNNAM. The drug is given 65mg twice a day for 48 days. clinical trial is conducted after conducting preclinical studies. The Siddha Drug is mentioned in THE PHARMACOPOEIA OF SIDDHA RESEARCH MEDICINES . During the trial all the study related data will be recorded and documented. After the completion of trial all the data will be analyzed statistically. |