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NCT07272993: GRIP-DN
Effect of Golden Rice-Piper Crocatum Cookies on Neuropathy Prevention in Diabetes
NA trial testing Golden Rice Cookies With Piper Crocatum in Diabetic Neuropathy in 102 participants. Participants enrolled and being followed up; not accepting new ones.
30 November 2025
Quick facts
| Lead sponsor | Hasanuddin University |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | supportive care |
| Enrollment | 102 |
| Start date | 20 October 2025 |
| Primary completion | 30 November 2025 |
| Estimated completion | 31 December 2025 |
| Sites | 1 location across Indonesia |
Drugs / interventions tested
- Golden Rice Cookies With Piper Crocatum
- Golden Rice Cookies Without Piper Crocatum
Conditions studied
- Diabetic Neuropathy — all drugs for Diabetic Neuropathy →
- Diabetes Mellitus (DM) — all drugs for Diabetes Mellitus (DM) →
- Functional Food — all drugs for Functional Food →
- Nutritional Intervention — all drugs for Nutritional Intervention →
Sponsor
Hasanuddin University
Who can join
Adults 18 to 59, any sex, with Diabetic Neuropathy or Diabetes Mellitus (DM). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Diabetes mellitus is a chronic disease that can cause many complications, one of the most common being diabetic neuropathy. This condition occurs due to long-term high blood sugar levels that damage the nerves. Symptoms include tingling, burning, pain, and loss of sensation in the feet. If not prevented, neuropathy can progress to diabetic foot ulcers and even lead to amputation. This study aims to evaluate whether Golden Rice Cookies enriched with Red Betel Leaf (Piper crocatum) can help prevent diabetic neuropathy in patients with diabetes. Golden rice is a type of rice that contains beta-carotene (provitamin A) and high fiber, which help maintain stable blood sugar levels and reduce oxidative stress. Meanwhile, red betel leaf contains flavonoids, polyphenols, and alkaloids with antioxidant, anti-inflammatory, and hypoglycemic properties that may protect nerves from damage. Cookies were chosen as the intervention form because they are practical, easy to consume, and widely accepted by patients. In this study, patients will be divided into two groups: an intervention group receiving golden rice cookies with red betel leaf extract, and a control group receiving golden rice cookies without the extract. Changes in neuropathy symptoms will be assessed using the Neuropathy Symptom Score (NSS) before and after the intervention. The expected outcome of this research is to provide scientific evidence that the combination of golden rice and red betel leaf in the form of cookies can serve as an effective, safe, and acceptable functional food to help prevent diabetic neuropathy. This nutritional intervention may support comprehensive diabetes management and improve patients' quality of life.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07272993
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Other Hasanuddin University trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07272993 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hasanuddin University
- Last refreshed: 9 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07272993.
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