Evaluation the efficacy of extract of Dracocephalum in chemotherapy

Evaluation the efficacy of hydroalcoholic extract of Melissa officinalis L. (Dracocephalum) in chemotherapy-induced peripheral neuropathy: A double-blinded randomized placebo-controlled clinical trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20201128049515N2

Enrollment

Registered

2021-04-22

Start date

2021-05-21

Completion date

Unknown

Last updated

2021-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chemotherapy induced peripheral neuropathy. Paraneoplastic neuromyopathy and neuropathy

Interventions

Intervention 1: Intervention group: beside the 300 mg daily dose of gabapentin will receive hydroalcoholic extract of Melissa officinalis L plant in capsule form (1 capsule containing 300 mg of the dr

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Patients with cancer between 18 to 75 years old Patients who has received their first neurotoxic chemotherapy by using Vinca alkaloids, platinum and taxane derivatives. Patients with neuropathy symptoms.

Exclusion criteria

Exclusion criteria: Other possible reasons for neuropathy (diabetes, thyroid function disorder, B12 deficiency, alcohol abuse) Taking other medications for neuropathy symptoms simultaneously Taking any type of anti oxidant supplements in recent two months Pregnant or nursing women

Design outcomes

Primary

Measure	Time frame
Chemotherapy induced peripheral neuropathy. Timepoint: At initial assessment and 1,2 and 3 month after initial assessment. Method of measurement: Performance status- Eastern Cooperative Oncology Group questionnaire (PS-ECOG).	—

Secondary

Measure	Time frame
The efficacy of treatment. Timepoint: At initial assessment of patient and 1, 2, and 3 month after the initial assessment. Method of measurement: Evaluation of neuropathy symptom alleviation and questionnaire.;Pain intensity. Timepoint: At initial assessment of patient and 1, 2, and 3 month after the initial assessment. Method of measurement: Based on visual analogue scale and questionnaire.;Adverse effects. Timepoint: At initial assessment of patient and 1, 2, and 3 month after the initial assessment. Method of measurement: Common Terminology Criteria for Adverse Events and questionnaire.;Quality of life. Timepoint: At initial assessment of patient and 1, 2, and 3 month after the initial assessment. Method of measurement: Questionnaire developed to assess the quality of life of cancer patients.	—

Measure

Time frame

The efficacy of treatment. Timepoint: At initial assessment of patient and 1, 2, and 3 month after the initial assessment. Method of measurement: Evaluation of neuropathy symptom alleviation and questionnaire.;Pain intensity. Timepoint: At initial assessment of patient and 1, 2, and 3 month after the initial assessment. Method of measurement: Based on visual analogue scale and questionnaire.;Adverse effects. Timepoint: At initial assessment of patient and 1, 2, and 3 month after the initial assessment. Method of measurement: Common Terminology Criteria for Adverse Events and questionnaire.;Quality of life. Timepoint: At initial assessment of patient and 1, 2, and 3 month after the initial assessment. Method of measurement: Questionnaire developed to assess the quality of life of cancer patients.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Ramin Shekarriz

Mazandaran University of Medical Sciences

r.shekarriz@mazums.ac.ir+98 11 3336 4044

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026