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IRCT20100127003210N33 IRCT 2026-04-29 Shahid Beheshti University of Medical Sciences Evaluating the Effectiveness of Nanocurcumin Capsules on oral ulcer in Patients Undergoing Hematopoietic Stem Cell Transplantation: A Randomized Triple-blind Placebo controlled Clinical trial Evaluating the Effectiveness of Nanocurcumin Capsules on Mucositis in Patients Undergoing Hematopoietic Stem Cell Transplantation: A Randomized Triple-blind Placebo controlled Clinical trial 2026-05-22 anticipated 110 Recruiting https://irct.ir/trial/89541 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: After obtaining informed consent, eligible patients are divided into two separate strata based on the type of transplant: autologous and allogeneic. In each stratum, randomization is performed with four-way random blocks and a 1:1 allocation ratio to the two arms of nanocurcumin (Group A) and placebo (Group B). The randomization sequence in each stratum is generated by computer and provided to the independent pharmacist in the form of coded block lists, Blinding description: This study is triple-blinded; patients, outcome assessor and data analyzer are unaware of the type of intervention (nanocurcumin or placebo) and only the pharmacist responsible for randomization has access to the code list. Randomization codes are kept in sealed, tamper-evident envelopes and remain confidential until data collection is complete and the database is locked, and will only be broken if necessary for safety or after completion of the primary analysis. Nanocurcumin and placebo capsules are identical in shape, size, color, and odor, and are distinguished only by unique alphanumeric codes on the packaging so that the allocation is not recognizable to the clinical team and patients. 3 Patients with various Blood Malignancies who are candidates for Hematopoietic Stem Cell Transplantation.. Intervention 1: Intervention group: Receive 3 capsules daily (one after each meal) of nanocurcumin containing 40 mg of curcuminoids in a highly bioavailable nanomicelle medium from Exir Nano Sina company, from two days before the start of chemotherapy until the engraftment and resolution of mucositis. Intervention 2: Control group: Receive 3 capsules daily (one after each meal) of placebo, from two days before the start of chemotherapy until the engraftment and resolution of mucositis. Yes - There is a plan to make this available What will be shared: Laboratory findings of patients along with statistical analysis can be shared without providing patients' names. When: 6 month after publishing the results, primary outcome data will be released. To whom: Doctors and other researchers Conditions: People such as hospital staff or other medical staff such as nurses and clinical pharmacists can use this information. Where to obtain: Researchers can contact the following email to receive information: mariatavakoli@yahoo.com How to obtain: People who intend to use the information must be affiliated with reliable organizations and their requests should be submitted through these organizations. In this context, there is a need for an introduction letter from the desired center. Comments:
public Maria Tavakoli Ardakani
Vali-e-asr Ave., Niayesh junction
Tehran Iran (Islamic Republic of) 1996835113 +98 21 8887 3704 mariatavakoli@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Maria Tavakoli Ardakani
Vali-e-asr Ave., Niayesh junction
Tehran Iran (Islamic Republic of) 1996835113 +98 21 8887 3704 mariatavakoli@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Age 18 to 70 years. Confirmation of HSCT candidacy by the transplant team. Adequate performance status, i.e. Eastern Cooperative Oncology Group (ECOG) score from 0 to 2. Ability to swallow and take capsules orally at the time of intervention and the possibility of taking them for at least one week after conditioning. Patients’ agreement to standard mucositis prevention care according to the center’s protocol (prevention: chlorhexidine and normal saline mouthwash, treatment: diphenhydramine + AlMg + nystatin + lidocaine cocktail and, if needed and available, gelclair mouthwash and mucosamine spray). Written informed consent. 18 years 70 years Both Known hypersensitivity to Curcumin, Turmeric, or components of the nanomicelle product. Chronic systemic corticosteroid use at a dose equivalent to >10 mg prednisone daily for 14 days prior to conditioning. Regular use of supplements or herbs with anti-inflammatory-antioxidant effects or containing Piperine for 7 days prior to conditioning, including high doses of vitamins A-C-E, selenium, non-study turmeric products, ginger, chamomile. Stable oral anticoagulant therapy or dual antiplatelet therapy that cannot be adjusted. Single low-dose aspirin use is acceptable and will be recorded. AST or ALT > 3 times the upper limit of normal, or total bilirubin > 2 times the upper limit of normal, or eGFR < 30 mL/min/1.73 m². Concurrent participation in another interventional trial that directly affects mucositis, sleep, appetite, or supportive care. Pregnancy or lactation. T86.0 Complications of bone marrow transplant Treatment - Drugs Placebo Intervention group: Receive 3 capsules daily (one after each meal) of nanocurcumin containing 40 mg of curcuminoids in a highly bioavailable nanomicelle medium from Exir Nano Sina company, from two days before the start of chemotherapy until the engraftment and resolution of mucositis. Control group: Receive 3 capsules daily (one after each meal) of placebo, from two days before the start of chemotherapy until the engraftment and resolution of mucositis. Determining the effect of nanocurcumin capsules on mucositis in patients undergoing autologous and allogeneic transplantation. Timepoint: From the onset of mucositis to the resolution of mucositis. Method of measurement: WHO mucositis grading scale. Determining the effect of nanocurcumin on the incidence and severity of oral mucositis in patients undergoing autologous and allogeneic transplantation. Timepoint: From the onset to the resolution of mucositis. Method of measurement: WHO mucositis grading scale. Determining the effect of nanocurcumin on the onset and termination time of oral mucositis in patients undergoing autologous and allogeneic transplantation. Timepoint: From the onset to the resolution of mucositis. Method of measurement: WHO mucositis grading scale. Determining the effect of nanocurcumin on the host incidence and severity of gastrointestinal mucositis in patients undergoing autologous and allogeneic transplantation. Timepoint: From the onset to the resolution of mucositis. Method of measurement: based on CTCAE v 5.0 criteria. Determining the effect of nanocurcumin on the appetite of patients undergoing autologous and allogeneic transplantation. Timepoint: Before intervention initiation, during chemotherapy or neutropenic period, after engraftment. Method of measurement: The Council on Nutrition Appetite Questionnaire (CNAQ). Determining the effect of nanocurcumin on sleep of patients undergoing autologous and allogeneic transplantation. Timepoint: Before intervention initiation, during chemotherapy or neutropenic period, after engraftment. Method of measurement: Pittsburgh Sleep Quality Index (PSQI). Determining the effect of nanocurcumin on the need for narcotic analgesics in patients undergoing autologous and allogeneic transplantation. Timepoint: From the beginning of intervention until resolution of mucositis and engraftment of patients. Method of measurement: Total morphine equivalent dose of prescribed opioids. Determining the effect of nanocurcumin on the need for total parenteral nutrition in patients undergoing autologous and allogeneic transplantation. Timepoint: From the beginning of intervention until resolution of mucositis and engraftment of patients. Method of measurement: Duration of need for total parenteral nutrition in patients. Determining the safety and side effects of nanocurcumin in patients undergoing autologous and allogeneic transplantation. Timepoint: Weekly from the onset of intervention until resolution of mucositis and engraftment of patients. Method of measurement: Questionnaire based on common adverse effect of nanocurcumin based on studies. Determining the effect of nanocurcumin on days of neutropenic fever in patients undergoing autologous and allogeneic transplantation. Timepoint: From the onset of intervention until resolution of mucositis and engraftment of patients. Method of measurement: Measurement of body temperature of patients during neutropenic period. Shahid Beheshti University of Medical Sciences Approved 2026-04-18 Ethics committee of Faculty of Pharmacy - Shahid Beheshti University of Medical Sciences Faculty of Pharmacy, Shahid Beheshti University of Medical Science, Valiasr St., Hashemi Rafsanjani Highway intersection., Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)