| CTRI Number |
CTRI/2022/02/040177 [Registered on: 10/02/2022] Trial Registered Prospectively |
| Last Modified On: |
09/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial on SARAKKONDRAI ILAI CHOORANAM in the management of MADHUMEGA AVATHAIGAL I-V (DIABETES MELLITUS AND ITS COMPLICATIONS) |
|
Scientific Title of Study
|
A prospective open labelled,non randomized, phase II clinical trial of SARAKKONDRAI ILAI CHOORANAM in the management of MADHUMEGA AVATHAIGAL I-V (DIABETES MELLITUS AND ITS COMPLICATIONS) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrKDPraise Prabha |
| Designation |
PG Scholar |
| Affiliation |
Government siddha Medical College and Hospital |
| Address |
Second year PG, Department of Pothu Maruthuvam,Op.No.10, Government siddha Medical College and Hospital, Palayamkottai, Tirunelveli
Second year PG, Department of Pothu Maruthuvam,OP.NO.10, Government siddha Medical College and Hospital, Palayamkottai, Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9481846922 |
| Fax |
|
| Email |
prabhapraise@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSJustus Antony MDsphD |
| Designation |
Lecturer |
| Affiliation |
Government siddha Medical College and Hospital |
| Address |
Department of Pothu Maruthuvam,OP.No.10, Government siddha Medical College and Hospital, Palayamkottai, Tirunelveli
Department of Pothu Maruthuvam, Government siddha Medical College and Hospital, Palayamkottai, Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443090849 |
| Fax |
|
| Email |
justusantony71@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ProfDrAManoharan MD s phD |
| Designation |
Professor and HOD |
| Affiliation |
Government siddha Medical College and Hospital |
| Address |
Department of Pothu Maruthuvam,OP.NO.10, Government siddha Medical College and Hospital, Palayamkottai, Tirunelveli
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
|
| OPD and IPD 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 |
| 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 |
| DrPraise Prabha |
Government siddha Medical College and Hospital |
Department of Pothu Maruthuvam Government siddha Medical College and Hospital, Palayamkottai, Tirunelveli
Tirunelveli
TAMIL NADU |
9481846922
prabhapraise@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: E00-E89||Endocrine, nutritional and metabolic diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
SARAKKONDRAI ILAI CHOORANAM |
1250-1500mg/Twice a day with hot water for 90 days |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
1.TypeII diabetes mellitus, previously diagnosed diabetic patients which are uncontrolled or poorly controlled for more than 2 years duration of the illness.2.Patients with symptoms of Polyuria, Polydipsia, Polyphagia, nocturia, numbness, tingling sensation.3.Patient willing to give blood and urine sample before and after the treatment.
|
|
| ExclusionCriteria |
| Details |
1.Age below 34 years and above 60years.2.TypeI diabetes mellitus 3.Gestational DM 4.Diabetes inisipidus 5.Pregnancy 6.Lactating mother 7. Chronic kidney disease 8. Chronic Liver disease 9.Ischemic heart disease 10. Other types of neuropathy |
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| If during treatment or after treatment 1.FBS became less than 126 mg/dl and PPBS less than 200 mg/dl and HbA1C less than 6.5 2.Reduction of the signs and symptoms of i.e.Polyuria, Polydypsia, Polyphagia, nocturia, numbness, tingling sensation,nausea.3.Achieving of optimal BMI 4.Achieving of optimal blood pressure (supine and erect positions) |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To evaluate the biochemical physico-chemical and phyto chemical analysis of clinical trial drug
2.To evaluate the antimicrobial activity of trial drug
3.To evaluate the safety profile for acute and subacute toxicity of the trial drug SARAKKONDRAI ILAI CHOORANAM
3.To evaluate Pharmacological analysis of the clinical trial drug
5.To evaluate Siddha parameters and modern parameters during the treatment of MADHUMEGA AVATHAIGAL I-V with trial drug
6.To evaluate the statistical analysis of the clinical trial drug SARAKKONDRAI ILAI CHOORANAM
7.To evaluate the powder microscopic study and HTPLC of the trial drug |
90days |
|
|
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)
|
12/02/2022 |
| 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 trial on SARAKKONDRAI ILAI CHOORANAM in the management of MADHUMEGA AVATHAIGAL I-V (DIABETES MELLITUS AND ITS COMPLICATIONS).The trial drug will be administered at the dose of 1250-1500 mg Twice a day orally A/F for 90 days along with hot water adjuvant in 40 patients.The trial period of 12 months will be carrying out in Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli.The primary outcome will be evaluation of therapeutic efficacy of trial drug SARAKKONDRAI ILAI CHOORANAM.The secondary outcome will be evaluation of siddha parameters, assessment of safety profile of trial drug, assessment of Pharmacological and biochemical parameters of trial drug.In case any adverse event (AE) is noticed and it will be referred to pharmacovigilance department of SCRI.Further management of patients wil be given in OPD facility. |