| CTRI Number |
CTRI/2019/12/022249 [Registered on: 03/12/2019] Trial Registered Prospectively |
| Last Modified On: |
29/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Other |
|
Public Title of Study
|
A Clinical Trail to Study The Effect Of Siddha Drug Mithran Ambu Chooranam In Patients Having Urolithiasis(Vatha kalladaippu) |
|
Scientific Title of Study
|
Phase II Non-randomized Open Clinical Evaluation Of Siddha drug Mithran ambu chooranam in Vatha Kalladaippu (Urolithiasis) -in Both Gender Age Between 18 to 60 Years patients Attending OPD at AAGHIM attached with GSMC |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Asai Maniraja |
| Designation |
PG Scholar |
| Affiliation |
Govt siddha medical college |
| Address |
Post Graduate
Department Of general medicine Govt Siddha medical college
6 anna arch road
nsk nagar
Arumbakkam
Chennai 600106
Chennai
TAMIL NADU
600106
India |
| Phone |
8940838908 |
| Fax |
|
| Email |
asaimakeitsimple@gamil.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anbu N |
| Designation |
HOD and Proffesor |
| Affiliation |
Govt siddha medical college |
| Address |
Post Graduate
Department Of general medicine Govt Siddha medical college
6 anna arch road
nsk nagar
Arumbakkam
Chennai 600106
Chennai
TAMIL NADU
600106
India |
| Phone |
8940838908 |
| Fax |
|
| Email |
nanbu.sumi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Asai Maniraja |
| Designation |
PG Scholar |
| Affiliation |
Govt siddha medical college |
| Address |
Post Graduate
Department Of general medicine Govt Siddha medical college
6 anna arch road
nsk nagar
Arumbakkam
Chennai 600106
Chennai
TAMIL NADU
600106
India |
| Phone |
8940898908 |
| Fax |
|
| Email |
asaimakeitsimple@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt siddha medical college 6 anna arch road nsk nagar arumbakkam chennai 600106 |
|
|
Primary Sponsor
|
| Name |
Govt siddha medical college |
| Address |
Govt siddha medical college 6 anna arch road nsk nagar arumbakkam chennai 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 Asai Maniraja |
Arignar Anna Hospital of Indian Medicine |
Out Patient Department-2
Siddha Wing
6, Anna arch road
Nsk Nagar
Arumbakkam
Chennai 600106
Chennai
TAMIL NADU |
8940838908
asaimakeitsimple@gamil.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: N23||Unspecified renal colic, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mithran ambu chooranam |
2.6 gm twice a day with palm jaggery for 10 days |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
presence of calculi in usg stone size 4 to 9 mm lower abdominal pain burning micturation oliguria dysurea haematuria |
|
| ExclusionCriteria |
| Details |
Stag horn calculus calculi associated with elevated serum creatinine level pregnancy hydronephrosis obstructive neuropathy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcome is mainly assessed by reduction in clinical symptoms and by comparing the following parameters before and after treatments. |
10 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcome is assessed by comparing the safety parameters before and after treatment |
1 year |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
13/12/2019 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a single non randomised open clinical trial to study the safety and efficacy of siddha trial drug mithran ambu chooranam. The trial drug is given 2.6 gm twice a day with palm jagggery for 10 days. clinical trial is conducted after conducting preclinical and toxicity study. The trial drug mithran ambu chooranam is mentioned in Anuboga vaithya perunkural. During the trial all the study related data will be recorded and documented after the completion of trial.All the data will be analysed statistically. |