| CTRI Number |
CTRI/2019/07/020396 [Registered on: 29/07/2019] Trial Registered Prospectively |
| Last Modified On: |
27/07/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to determine the efficacy of avala veera chunnam on gallbladder stone |
|
Scientific Title of Study
|
A pilot study on calculus cholecystitis (gallbladder stone/pithapaikal) managed with siddha formulation of pavalaveera chunnam |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr B Muthu karthikeyan |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
OP no 5,
Department of NoiNaadal,
National Institute of siddha, Tambaram sanatorium, chennai.
OP no 5,
Department of NoiNaadal,National Institute of siddha, Tambaram sanatorium, chennai.
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
8903441419 |
| Fax |
|
| Email |
b.m.k.keyan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G J Christian |
| Designation |
Head of the Department |
| Affiliation |
National Institute of Siddha |
| Address |
OP no 5,
Department of NoiNaadal,National Institute of siddha, Tambaram sanatorium, chennai.
OP no 5,
Department of NoiNaadal,National Institute of siddha, Tambaram sanatorium, chennai.
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9962545930 |
| Fax |
|
| Email |
christianvijila@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr B Muthu karthikeyan |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
OP no 5,
Department of NoiNaadal,National Institute of Siddha, Tambaram Sanatorium, Chennai
OP no 5,
Department of NoiNaadal,National Institute of Siddha, Tambaram Sanatorium, Chennai
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
8903441419 |
| Fax |
|
| Email |
b.m.k.keyan@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Siddha |
|
|
Primary Sponsor
|
| Name |
National Institute of Siddha |
| Address |
National Institute of Siddha, Tambaram Sanatorium, chennai |
| 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 |
| Dr B Muthu karthikeyan |
National Institute of Siddha |
OP no 5,
Department of NoiNaadal,National Institute of Siddha,
Tambaram Sanatorium, Chennai.
Kancheepuram
TAMIL NADU |
8903441419
b.m.k.keyan@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: K800||Calculus of gallbladder with acutecholecystitis, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Asymptomatic cholelithiasis
the patients of cholelithiasis as diagnosed by USG Abdomen,
Gallbladder stone size less than 10mm. |
|
| ExclusionCriteria |
| Details |
Pregnant and lactating mothers,
cholecystitis with pancreatitis as diagnosed by USG abdomen,
Obstructive Jaundice,
Gallstone patients with other comorbidities,
patients who did not give consent to join study,
malignancy of gallbladder as by reports. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The outcome of the study is assessed by reduction in clinical symptoms and reduction in the size of the stone with interpretation of USG abdomen. |
2 months with follow once in a week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="5"
Sample Size from India="5"
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)
|
05/08/2019 |
| 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
|
this article will be publish after finishing the study. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Siddha system of medicine is one of the ancient system of medicine. In siddha system of medicine had 4448 types of disease divided by the great saint’s 18 Siddhars and give a natural types of mecines for above diseases. In this study we have to manage The Cholelithiasis (Gallbladder stone/ Pithapai kal) with siddha fromulation of Pavala Veera Chunnam. In my study patients are selected by selection criterias and found outcome after 2 months with interpretation of USG Abdomen reports. After finishing above study and results of drug on Pithpai kal will be published. |