Evaluation of glycemic control in type 2 diabetes patients using Diafree juice
| ISRCTN | ISRCTN16382675 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16382675 |
| Secondary identifying numbers | KAA/RD/PMS-DF/2024/001 |
- Submission date
- 03/07/2025
- Registration date
- 29/07/2025
- Last edited
- 25/07/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
This study aims to assess how effective a herbal product called Diafree Juice is in helping people with type 2 diabetes manage their blood sugar levels. Diafree Juice is an Ayurvedic formulation already being used by patients as part of their regular diabetes care. The study analyzes anonymized health data shared by physicians to understand if Diafree Juice leads to improvements in two key measures of blood sugar: HbA1c and post-meal glucose levels.
Who can participate?
People diagnosed with type 2 diabetes, aged 18 years or older, with HbA1c values between 5.5% and 7% who have already been prescribed Diafree Juice by their doctor as part of routine treatment.
What does the study involve?
There is no direct involvement from patients. Doctors who are already treating these individuals shared anonymized health records, including blood sugar levels before and after the use of Diafree Juice. The study does not require any new medication, lab tests, or visits.
What are the possible benefits and risks of participating?
There are no direct risks or benefits to the patients included in this study. Since the study only uses anonymized data that was already collected as part of routine care, there is no additional burden or intervention for patients. The results of this study may help inform future research and improve clinical understanding of the product's role in diabetes management.
Where is the study run from?
The study is coordinated by the Kapiva Academy of Ayurveda in Bengaluru, India, using data collected from Ayurvedic doctors across the country.
When is the study starting and how long is it expected to run for?
April 2024 to December 2024
Who is funding the study?
The study is funded and sponsored by Adret Retail Private Limited (Kapiva Ayurveda), based in Bengaluru, India.
Who is the main contact?
Dr Anushri Shah, anushri.shah@kapiva.in
Contact information
Scientific, Principal Investigator
KAPIVA ACADEMY OF AYURVEDA, 118/2 Doddakannenahalli Village,Varthur Hobli, Sarjapur - Marathahalli Rd, Next to August grand Apartments
Bengaluru, Karnataka
560035
India
| Phone | +91 8588825824 |
|---|---|
| anushri.shah@kapiva.in |
Public
Digicare Healthcare Solutions Private Limited
Ahmedabad
380058
India
| Phone | +91 8290799906 |
|---|---|
| patientsafety@tatvacare.in |
Study information
| Study design | Open-label prospective single-arm observational |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Medical and other records |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Evaluating the effect of Diafree Juice on blood sugar control in type 2 diabetes: a retrospective study |
| Study objectives | Diafree Juice reduces HbA1c and postprandial plasma glucose (PPBG) in patients with type 2 diabetes mellitus over a 12-week period. |
| Ethics approval(s) | Ethics approval not required |
| Health condition(s) or problem(s) studied | Type 2 Diabetes Mellitus |
| Intervention | Participants included in this study were individuals with type 2 diabetes who had already been prescribed Diafree Juice by their treating physicians as part of routine care. The study did not involve any new intervention, enrolment, or patient contact. Physicians shared anonymized clinical data for eligible patients, including HbA1c and postprandial plasma glucose (PPBG) levels at baseline (prior to Diafree Juice initiation) and after approximately 12 weeks (84 days) of continued product use. No additional follow-up or study procedures were required beyond standard medical care. The total duration of observation per patient was 12 weeks. |
| Intervention type | Other |
| Primary outcome measure | HbA1c level measured using laboratory test results reviewed from patient medical records maintained by treating physicians at Baseline (prior to Diafree Juice initiation) and after 12 weeks (Day 84) |
| Secondary outcome measures | Postprandial Plasma Glucose (PPBG) (mg/dL) measured using laboratory test results reviewed from patient medical records maintained by treating physicians at Baseline (prior to Diafree Juice initiation) and after 12 weeks (Day 84) |
| Overall study start date | 01/04/2024 |
| Completion date | 31/12/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 82 |
| Total final enrolment | 82 |
| Key inclusion criteria | Diagnosed T2DM with HbA1c 5.5–7% |
| Key exclusion criteria | 1. Type 1 DM, insulin therapy 2. Fluctuating OHA doses 3. Contraindication to herbal use |
| Date of first enrolment | 15/04/2024 |
| Date of final enrolment | 27/12/2024 |
Locations
Countries of recruitment
- India
Study participating centre
India
Sponsor information
Industry
No 16-1 and 17-2
Vaishnavi Tech Park
Ambalipura Village
Varthur Hobli, Varthur
Bengaluru, Karnataka
560103
India
| Phone | +91 9481813428 |
|---|---|
| govindarajan@kapiva.in |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 10/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal |
| IPD sharing plan | Participant-level data will not be shared due to confidentiality and data protection policy. Only aggregate results will be disseminated. |
Editorial Notes
25/07/2025: Trial's existence confirmed by Adret Retail Pvt. Ltd.
