Efficacy of Celosia argentea Linn. Seeds in Management of Type 2 Diabetes Mellitus: A Randomized, Double-Blind, Placebo-controlled Clinical Trial.

BACKGROUND

Type 2 diabetes mellitus (T2DM) is among the most rapidly escalating global health crises of the 21st century. Conventional pharmacological management has unnecessary side effects. Therefore, exploring a safe and effective drug to manage T2DM is a foremost priority.

PRIMARY STUDY

OBJECTIVES

To evaluate the impact of Survali (Celosia argentea Linn.) seeds as an adjuvant medication in T2DM.

METHODS

Forty participants with T2DM were randomly assigned to test (n=20) and control (n=20) groups in a randomized, double-blind, placebo-controlled trial.

INTERVENTION: For 8 weeks, the test group received Celosia argentea Linn. seed powder, and the control group received roasted wheat flour; both were administered 4 g/day in two equal divided doses with water as a complement to conventional medicine.

PRIMARY OUTCOME MEASURES: HbA1c was assessed at baseline and at the end of the treatment.

SECONDARY OUTCOME MEASURES: These include changes in fasting and postprandial blood sugar, and the Asian Diabetes Quality of Life Questionnaire (ADQOL). Subjective parameters (polyphagia, polydipsia, polyuria, and tiredness) were assessed by an arbitrary scale fortnightly.

SETTING

This clinical trial was conducted at the National Institute of Unani Medicine, Bengaluru, India.

RESULTS

All 40 participants completed the study. The test drug showed a statistically significant difference in HbA1c and ADQOL (P < .001). However, the control group demonstrated no significant impact on any of the measures. A significant reduction in fasting blood sugar was observed in the test group, compared to baseline (P = .01), while no such significant changes were observed in the control group. The subjective parameters were non-significant, as both groups showed similar reduction in symptoms (P > .05). There was no significant difference between the groups in terms of safety parameters.

CONCLUSION

Celosia argentea Linn. seeds demonstrate efficacy as an adjuvant in the management of T2DM; further research is warranted to confirm the long-term efficacy and safety.

KEYWORDS: Fasting Blood Sugar, Unani Medicine, Postprandial Blood Sugar, HbA1c, Asian Diabetes Quality of Life Questionnaire.