A clinical trial on SARAKKONDRAI ILAI CHOORANAM in the management of MADHUMEGA AVATHAIGAL I-V (DIABETES MELLITUS AND ITS COMPLICATIONS)

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)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/02/040177

Enrollment

Registered

2022-02-10

Start date

Unknown

Completion date

Unknown

Last updated

2022-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: - Health Condition 2: - Health Condition 3: E00-E89- Endocrine, nutritional and metabolic diseases

Interventions

Intervention1: SARAKKONDRAI ILAI CHOORANAM: 1250_1500mg/Twice a day (orally) with hot water Intervention2: SARAKKONDRAI ILAI CHOORANAM: 1250-1500mg/Twice a day with hot water for 90 days Control Inter

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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)Timepoint: 90 days	—

Secondary

Measure	Time frame
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 drugTimepoint: 90days	—

Measure

Time frame

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 drugTimepoint: 90days

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Countries

India

Contacts

Public ContactProfDrAManoharan MD s phD

Government siddha Medical College and Hospital

justusantony71@gmail.com9443090849

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026