14th November 2022, New Delhi: Kapiva, a homegrown Ayurveda brand, recently conducted an AYUSH-approved single-arm, open-label clinical trial to prove the efficacy of Kapiva Dia Free Juice in the management of Diabetes Mellitus and improving the quality of life. Made with Ayurvedic herbs like Amla, Karela, Jamun, Giloy, Neem, Methi Gudmar, and others, the juice is found to be effective in lowering Fasting Blood Sugar (FBS) and Post-Prandial Blood Sugar (PPBS) value up to 30%*. It has also proven to be effective in decreasing HbA1c to an extent of 11%* and increasing insulin production in the body by up to 25-30%*.
This study was conducted in compliance with the approved protocol, and requirements of the ICMR ethical guidelines, GCP (Good clinical practices), and schedule Y. The study was conducted over a period of 3 months and changes in the diabetic panel, i.e., glycosylated hemoglobin (HbA1C), fasting blood sugar, and postprandial blood sugar (after a meal) were measured. In order to evaluate improvement in quality of life, reduction in Body mass index (BMI) and any notable changes in hematology and biochemistry profile were also measured.
Dr. Rajendra Sharma, Principal Investigator of the trial, said “Based on the lab reports & patient feedback on the quality of life, the Kapiva Dia-free Juice was found to be effective and safe. The Kapiva Dia-free Juice was safe for use in the recommended dosage. Kapiva Dia-free Juice helps in reducing the fasting blood sugar, post-prandial blood sugar, controlling HbA1C values.”
Dr. Kriti Soni, R&D Head, Kapiva, said, “We relentlessly work towards improving the efficacy of our products. Therefore, we are happy to see the results Kapiva Dia Free Juice has delivered. AYUSH-approved clinical trial has found the juice to be effective in reducing Fasting Blood Sugar (FBS) and Post-Prandial Blood Sugar (PPBS) values by 30%* by 3 Months of consumption. We’ll continue to invest in R&D to empower people around the globe with modern and accessible Ayurveda.”
Type 2 diabetes patients enrolled in the study underwent an initial screening to assess eligibility for the trial. Exclusion and inclusion criteria for the patients were clearly defined in the protocol and approved by regulatory bodies. Once screened, the patients were enrolled in the study and followed up. Patients were educated on the juice and the right way of consumption and the right way of recording blood glucose values using a glucometer. Simple diet guidelines were also explained.
HbA1c and other blood parameters such as FBS, PPBS, SGOT, SGPT, and C Peptide were conducted as per visit wise schedule. In total there were 8 visits scheduled over a period of 3 months to collect data from the patients.
At the end of the study and consumption period of three months, the following was observed:
- Reduction in fasting blood sugar value by up to 30%
The mean value of fasting blood sugar at the beginning of the trial was 211.3 mg/dl and 147.8 mg/dl at the end of the study with a mean value difference of 63.5 which is almost a 30% drop in FBS value with a statistical significance
- Reduction in postprandial blood sugar level by up to 33.1%
At the beginning of the trial, the mean value of post-prandial blood sugar level was 254.9 mg/dl at baseline and 170.5 mg/dl at end of the study with a mean difference of 84.4 which is almost a 33.1% drop in PPBS value with statistical significance.
This indicates that the juice helped in reducing the levels of blood sugar in fasting and after meals.
- Reduction in HbA1c (blood glucose) up to 11.1%
The HbA1c test measures the amount of blood sugar (glucose) attached to hemoglobin. It is an important blood test that indicates how well the diabetes is being controlled. In the present study, at baseline, the mean score was 9.36 and at the end of the Study visit, the mean score was 8.32. The mean difference was 1.04 (11.1% drop) which was statistically significant. This corresponds to an almost 1-point drop in HbA1c levels. This indicates that the juice helps in the reduction of blood glucose and maintenance of good blood glucose levels over a period of time.
- Helps in optimizing the function of C-peptide
C peptide is a marker that indicates the amount of Insulin produced by the body. Extremely high and low levels of C peptide can both indicate that there is an impairment in the way blood sugar is being controlled. In type 2 Diabetes, patients usually have very high levels of this marker which is a result of high blood glucose levels. In the present study, the values were 4.13 at baseline and reduced to 2.94 at EOS with a difference of 1.19 which was statistically significant for a p-value of 0.01. This infers that the Diafree juice helps in the regulation of blood sugar levels and thereby optimizing the function of C peptide function to an optimal range. This indicates that insulin production in the body went up by 25-30% at the end of the trial.
- Helps in stabilizing BMI
BMI was calculated at the baseline and at the end of the study. The BMI mean value was 28.37 kg/m2 at baseline and 27.54 kg/m2 at EOS with a mean difference of 0.83. The inference drawn by the investigative team is that Dia Free juice helps regulate BMI by influencing C-Peptide & HbA1C levels. This is an indirect parameter and is clinically significant to indicate improvement in participants’ quality of life. This corresponds to about a 2.2 kg reduction in body weight.
- Helps in maintaining biochemistry and hematology parameters
Biochemistry and hematology parameters were carried out at baseline and end of the study visit for safety assessments. The data at the end of the visit indicated values within normal ranges thereby signifying the juice is safe to consume.
