| CTRI Number |
CTRI/2021/01/030756 [Registered on: 27/01/2021] Trial Registered Prospectively |
| Last Modified On: |
18/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Other |
|
Public Title of Study
|
A clinical study on Oorithalthaamarai Chooranam in the management of Madhumegha noi muthalavathu Avasthai |
|
Scientific Title of Study
|
A Prospective Open Labelled non randomized phase II Clinical study On Oorithalthaamarai Chooranam in the management of Madhumegha noi muthalavathu avasthai – parutha udal
(Diabetic Dyslipidemia)
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
S HARISH TITTO |
| Designation |
PG SCHOLAR |
| Affiliation |
Government Siddha Medical College and Hospital Palayamkottai |
| Address |
II Year PG Scholar Department of Pothu Maruthuvam Government Siddha Medical College and Hospital Palayamkottai
Tirunelveli TAMILNADU
627002 INDIA
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8903660370 |
| Fax |
|
| Email |
harishtitto94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A Manoharan MD PhD |
| Designation |
Professor and HOD |
| Affiliation |
Government Siddha Medical College and Hospital Palayamkottai |
| Address |
Department of Pothu Maruthuvam Government Siddha Medical College and Hospital Palayamkottai
Tirunelveli TAMILNADU
627002 INDIA
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443886700 |
| Fax |
|
| Email |
drmanoharan25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr A Manoharan MD PhD |
| Designation |
Professor and HOD |
| Affiliation |
Government Siddha Medical College and Hospital Palayamkottai |
| Address |
Department of Pothu Maruthuvam Government Siddha Medical College and Hospital Palayamkottai
Tirunelveli TAMILNADU
627002 INDIA
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443886700 |
| Fax |
|
| Email |
drmanoharan25@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD and IPD facilities and Central Library of Government Siddha Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
OPD and IPD facilities and Central Library Government Siddha Medical College and Hospital |
| Address |
Government Siddha Medical College and Hospital Palayamkottai Tirunelveli Tamilnadu 627002 |
| 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 |
| S HARISH TITTO |
Government Siddha Medical College |
OPD and IPD of Department of Pothu Maruthuvam Government Siddha Medical College and Hospital Palayamkottai
627002 Tirunelveli TAMILNADU
Tirunelveli
TAMIL NADU |
8903660370
harishtitto94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Oorithalthaamarai Chooranam |
30 mg/kg/BW/twice a day A/F
90 Days |
|
|
Inclusion Criteria
|
| Age From |
31.00 Year(s) |
| Age To |
68.00 Year(s) |
| Gender |
Both |
| Details |
1. Type 2 diabetes mellitus
2. If yes in any of three
As per ADA
a. FBS - > 126mg/dl and
b. PPBS - >140mg/d land
c. HbA1c > 6.5
3. Secondary hyperlipidemia, Dyslipidemia has values as per NCEP
a. Total cholesterol - >199 mg/dl or
b. LDL - >100-129mg/dl or
c. Triglycerides - >150-199 mg/dl.
d. HDL level - ≤50-60 mg /dl
4. Willing to give blood sample for the investigations
|
|
| ExclusionCriteria |
| Details |
1.If yes in any one of three
a. FBS - < 126mg/dl and
b. PPBS - <140mg/dl and HbA1c < 6.5
2.High lipid profile, dyslipidemia has values of,
a. Total cholesterol <199 mg/dl
b. LDL <100-130 mg/ dl
c. Triglycerides <150-199 mg/dl
d. HDL level -≥50-60 mg /dl
3.Type 1 diabetes mellitus
4.Severe Hypertension
5.Pregnancy
6.Lactating mother
7.Chronic kidney disease / Renal failure
8.Chronic active viral hepatitis/cirrhosis/ascites
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
During treatment or after treatment,
FBS became 110mg /dl & PPBS160mg/dl and HbA1c 6.5.
Total cholesterol 199 mg/dl, LDL 159 mg/ dl and Triglycerides 150 mg/dl
|
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Evaluation of safety profile for acute& sub acute toxicity of the trial drug.
2.Evaluation of primary phytochemical analysis in different solvents.
3.Evaluation of pharmacological activities including anti-oxidant property of the trial drug.
4.Evaluation of anti microbial activity in different solvents of the clinical trial drug.
5.To develop clinical documents and literary evidence to support the effect of trial drug.
|
90 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/02/2021 |
| Date of Study Completion (India) |
29/10/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
The study is a prospective open labelled phase II non-randomized clinical study to evaluate the therapeutic efficacy of Oorithalthaamarai Chooranam in the management of Madhumegha Noi muthalavathu avasthai - parutha udal (Diabetic Dyslipidemia). The trial drug wilI be administered at the dose of 30 mg/ kg /BW/Twice a day A/F 90 days along with water as adjuvant in 60 patients. The trial period of 12 months will be carrying out in Government Siddha Medical College and Hospital Palayamkottai Tirunelvelli Tamilnadu. The primary outcome will be evaluation of therapuetic efficacy of trial drug Oorithalthaamarai Chooranam. The secondary outcome will be the evaluation of Siddha diagnostic parameters,assessment of safety profile of trial drug, assessment of pharmacological and biochemical parameters of the trial drug. In case of any adverse event (AE) is noticed and it will be referred to pharmacovigilance department of SCRI. Further management of patient will be given in OPD facility. |