Home » Trials » SLCTR/2015/008
Hypoglycaemic and antioxidant activity of the Siddha medical preparation “Mathumeha chooranam” in patients with diabetes mellitus
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SLCTR Registration Number
SLCTR/2015/008
Date of Registration
The date of last modification
Oct 04, 2024
Trial Status
Scientific Title of Trial
Hypoglycaemic and antioxidant activity of the Siddha medical preparation “Mathumeha chooranam” in patients with diabetes mellitus
Public Title of Trial
Study of efficacy of the Siddha medical (herbal) preparation “Mathumeha chooranam” on diabetes mellitus
Disease or Health Condition(s) Studied
Diabetes mellitus
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
J/ERC/13/41/DR/0009 (University of Jaffna)
What is the research question being addressed?
What is the hypoglycaemic and antioxidant effect of the Siddha medical preparation “Mathumeha chooranam” in patients with type 2 diabetes in Vadamaradchy south west Piradesha sabah area, Jaffna?
Type of study
Interventional
Study design
Allocation
Single arm study
Masking
Single blinded
Control
Standard therapy/practice
Assignment
Single
Purpose
Treatment
Study Phase
Phase 2
Intervention(s) planned
Participants will be recruited from the Rural Ayurvedic Hospital,Karaveddy and the Government Siddha Ayurvedic medical Clinics functioning under Vadamarachi South West Piradesha sabba, Jaffna District.
The interventional product will be prepared according to the Siddha pharmacopeia (P. Ramanathan, 2000). The collected leaves of Gymnema sylvestre (Small Indian ipecacuanha), Murraya keonigii (Curryleaf), ripe fruit of Pyllanthus emblica (Indian gooseberry) without seed and skin of the Terminalia chebulla (Chebulic Myrobalam) seed. The components will be dried thoroughly under shade and powdered. The powdered materials will be sieved up to 60/80 meshes and stored in an air tight container.
The maximum prescribed dose is 5g twice a day to be consumed with hot water after meals. The dose will be titrated according to the blood glucose level (if blood glucose <200mg/dl, 5g of the product to be taken once daily and if blood glucose is >200mg/dl, 5g of the product to be taken twice daily).
Total duration of treatment is 3 months.
Subjects will be requested not to seek therapy from any other alternative medicinal system (allopathic, homeopathy, acupuncture, and acupressure etc).
Inclusion criteria
Exclusion criteria
Primary outcome(s)
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1.
Fasting blood glucose 2. Lipid profile 3. Alanine amino transferase 4. Aspartate amino transferase 5. Alkaline Phosphatase 6. Total antioxidant capacity of serum by Ferric reducing ability of plasma (FRAP method) |
[ All investigations will be done on the 1st day, to establish a baseline, and then according to the following schedule.
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Secondary outcome(s)
|
1.
Patient symptoms as recorded in patient diary: Thirst, hunger and frequency of urination at day and at night 2. Random blood glucose 3. Fasting blood glucose 4. HbA 1c 5. Urine for reducing substances (Benedict’s test) 6. Urine for ketones |
[ Day 7, 14, 21, 28, 35, 42 and 49 and then monthly interval up to 3 months ] |
Target number/sample size
280
Countries of recruitment
Sri Lanka
Anticipated start date
2015-10-01
Anticipated end date
2016-03-01
Date of first enrollment
2016-04-08
Date of study completion
2020-10-28
Recruitment status
Complete: follow up continuing
Funding source
National Center for advanced studies and humanities
Regulatory approvals
Status
Approved
Date of Approval
2014-06-05
Approval number
J/ERC/13/41/DR/0009
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Jaffna |
| Institutional Address: | ERC Office, Faculty of Medicine, University of Jaffna, Adiyapatham Road, Kokuvil, Jaffna Sri Lanka |
| Telephone: | +94-212222073 (Extension: 342) |
| Email: | ercmedjfn@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr Mrs T Kumutharanjan
Senior Lecturer Gr 1
Unit of Siddha Medicine, University of Jaffna
Tel: 0214925190
Mob: 0777049458
Fax: 0212222294
tkumutharanjan@yaho.com
Contact Person for Public Queries
Dr. R. Sivaraman,
Consultant Physician,
Base Hospital,
Point Pedro
Mob: 0773601880
drsivaraman@yahoo.com
Primary study sponsor/organization
National Centre for Advanced Studies in Humanities & Social Sciences
6A, Sukhastan Gardens
Ward Place
Colombo – 07.
Sri Lanka
Tel: +94112685850, +94112693974
Fax: +94112693975
info@ncas.ac.lk
Web: www.ncas.ac.lk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
Yes
Date of posting results
Date of study completion
2020-10-28
Final sample size
193
Date of first publication
Link to results
Brief summary of results
A paired t-test was used to assess the statistical significance between 0 week and final measurements. Paired t-test revealed that the fasting plasma glucose (p<0.001) and HbA1c (p<0.001) significantly reduced after “Mathumeha Chooranam” administration. Beneficial Effect of “Mathumeha Chooranam” is high in Pitha pirakruti. And least in vatha pirakruti. Hypoglycaemic effect is significant in all three pirakiruthies. Paired t-test revealed that the Cholesterol (p<0.001). Triglycerides (p<0.001), HDL (p<0.0013), LDL (p<0.000), Cho/HDL (p<0.045), significantly reduced after “Mathumeha Chooranam” administration. “Mathumeha Chooranam” also demonstrated a significant reduction in the Lipid profile of the study participants. The AST and ALT levels were well within the normal range, The Ferric Reducing Antioxidant Power (FRAP) of the serum in the study participants significantly increased after 12 week of “Mathumeha Chooranam” intervention. ALP activity and serum creatinine level significantly decreased (p<0.001) in treated diabetic mellitus patients as well as in pitta pirakruti.than kapha and vatta pirakruti.The results suggest “Mathumeha Chooranam” to be beneficial for the treatment of type II diabetes Mellitus.
