| CTRI Number |
CTRI/2021/02/031369 [Registered on: 17/02/2021] Trial Registered Prospectively |
| Last Modified On: |
05/02/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Other |
|
Public Title of Study
|
A Clinical study on AMIRDHAVALLI CHOORANAM in the management of Madhumegam(Diabetes Mellitus) |
|
Scientific Title of Study
|
A Prospective Open Labelled Phase II Non-Randomized Clinical Trial on AMIRDHAVALLI CHOORANAM in the Management of Madhumega Noi(Diabetes Mellitus) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MNaga Lakshmi |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
PG department of pothu maruthuvam,op no.10,
Government Siddha Medical College and Hospital
Palayamkottai
Tirunelveli
PG department of pothu maruthuvam,op no.10
, Government Siddha Medical College and Hospital
Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8489299310 |
| Fax |
|
| Email |
nagalakshmimuthumalai@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrAManoharan MD s Ph D |
| Designation |
Professor and HOD |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
PG Department of Pothu Maruthuvam, op no. 10,
Government Siddha Medical College and Hospital
Palayamkottai
Tirunelveli
PG Department of Pothu Maruthuvam, op no. 10,
Government Siddha Medical College and Hospital
Palayamkottai
Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443886700 |
| Fax |
|
| Email |
drmanoharan25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrAManoharan MD s Ph D |
| Designation |
Professor and HOD |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
PG Department of Pothu Maruthuvam, op no. 10,
Government Siddha Medical College and Hospital
Palayamkottai
Tirunelveli
PG Department of Pothu Maruthuvam, op no. 10,
Government Siddha Medical College and Hospital
Palayamkottai
Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443886700 |
| Fax |
|
| Email |
drmanoharan25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Out patient department and In patient department facilities and central Library of Government Siddha Medical College and Hospital. |
|
|
Primary Sponsor
|
| Name |
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 |
| MNaga Lakshmi |
Government Siddha Medical College and Hospital |
Op no. 6&10,IP no. 19,20,22,23,27 OPD & IPD of Pothu Maruthuvam
Tirunelveli
TAMIL NADU |
8489299310
nagalakshmimuthumalai@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Amirdhavalli Chooranam |
50mg/kg/BW/twice a day( orally)A/F 45 days |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
Type II diabetes mellitus,previously diagnosed diabetic patients which are uncontrolled or poorly controlled for more than 2 years duration of the illness
Even if the patient is having any one among the three:
FBS-126mg/dl to 250mg/dl
PPBS-200mg/dl to 350mg/dl
HbA1C-6.5-10
Patients with symptom of polyuria, polydipsia,polyphagia,asthenia,nocturia,obesity,numbness,tingling sensation,mood changes and irritability. |
|
| ExclusionCriteria |
| Details |
Age below 35 yrs above 60 yrs
Type I DM
Gestational DM
Diabetes insipidus
Pregnancy/lactating mother
Chronic kidney disease
Chronic liver disease
Ischemic heart disease |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To develop evidence support for the effect of AMIRDHAVALLI CHOORANAM in the management of Madhumega Noi(Diabetes Mellitus) |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To collect various siddha literatures and modern journals
To evaluate Physio chemical,Phyto chemical,Bio-chemical analysis
To study the anti-microbial activity for selected micro organisms
To evaluate Pharmacological activity,Safety profile for acute and subacute toxicity of trial drug
To evaluate the efficacy of Amirdhavalli Chooranam on Madhumegam by the Bio-Statistical analysis |
45 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
02/04/2021 |
| 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)?
Response - NO
|
|
Brief Summary
|
The study is a prospective open labelled non randomized phase II clinical study on Amirdhavalli Chooranam in the management of Madhumega noi(Diabetes mellitus). The trial drug will be admistrated at the dose of 50mg/kg/BW/twice a dayA/F 45 days along with Hotwater as adjuvant in 60patients.The trial period of 12 months will be carrying out Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli, Tamilnadu. The primary outcome will be evaluation of therapeutic efficacy of trial Drug AMIRDHAVALLI 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 trial drug.Incase of any adverse event(AE) is noticed and it will be prefered to pharmacovigilance department of SCRI. Further management of the patient will be given in OPD facility. |