A clinical trial to study the effects of a Polyherbal Siddha drug, "Atthippattaiyathi Kasayam" in patients with Type 2 Diabetes Mellitus (Mathumegam).

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2014/11/005185
• Date of registration: 07-11-2014
• Prospective Registration: No
• Primary sponsor: national institute of siddha
• Public title: A clinical trial to study the effects of a Polyherbal Siddha drug, "Atthippattaiyathi Kasayam" in patients with Type 2 Diabetes Mellitus (Mathumegam).
• Scientific title: Preclinical and Clinical study on â??MATHUMEGAMâ?? (Type-2 Diabetes Mellitus) and the drug of choice is â??ATTHIPPATTAIYATHI KASAYAMâ?? (Internal).
• Date of first enrolment: 22-07-2012
• Target sample size: 40
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=4455
• Study type: Interventional
• Study design: Single Arm Trial; Method of generating randomization sequence:Other Method of allocation concealment:Other Blinding and masking:Open Label
• Phase: Phase 3

Countries of recruitment

India

Contacts

• Name: Dr H Nalini Sofia
• Affiliation: National Institute of Siddha

• Name: Dr H Nalini Sofia
• Affiliation: National Institute of Siddha

Key inclusion & exclusion criteria

Inclusion criteria: Polyuria,

Nocturia,

Polydipsia,

Polyphagia,

Body pain,

Weight gain(obesity),

Tiredness,

Burning feet,

genital pruritus,

Diabetes defined as those patients with Fasting plasma glucose level 126 to 180 mg/dl,

2 hours postprandial plasma glucose level 200 to 300 mg/dl
Exclusion criteria: IDDM,

Diabetic complications like microvascular and macrovascular complications etc,

Cardiac diseases,

Pulmonary diseases,

Renal diseases,

Thyroid dysfunctions,

Gestational diabetes,

Other endocrine abnormalities,

Patient who are not willing to give blood sample

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Mathumegam (Type-2 Diabetes Mellitus)

Intervention(s)

Intervention1: NIS/IEC/2011/3/07 - 24/12/2011: Atthippattaiyathi kasayam 336 ml tds for 40 days oral
Intervention2: Atthippattaiyathi Kasayam: 336 ml (Internal) TID for 40 Days
Control Intervention1: Atthippattaiyathi Kasayam
336 ml tds for 40 days: Atthippattaiyathi kasayam is a decoction form of internal(oral) medicine, 336 ml of decoction take oraly before food three times per day for 40 days. every time decoction is freshly prepared by the following method, Take 5gm of Atthippattaiyathi kasayam powder and add 1.3 litre of water, boil it to reduce 1/4th of the part, ie 336 ml.
Control Intervention2: NIL: NIL

Primary Outcome(s)

Primary outcome:

The outcome is mainly assessed by comparing the pre and post treatment blood glucose level of the trial patient.

Timepoint: 40 days

Secondary Outcome(s)

secondary outcome is assessed by comparing the pre and post siddha and clinical parameters and investigation parameters like lipid frofile.Timepoint: 40 days

Secondary ID(s)

NIL

Source(s) of Monetary Support

Ayothidoss Pandithar Hospital, Chennai.

Ethics review

Status: Approved
Approval date: 24/12/2011
Contact:

Institutional Ethical Committee, National Institute of Siddha