Health Condition 1: 8- Other Procedures
Conditions
Interventions
None listed
Sponsors
BOMBAY HEMP COMPANY PVT. LTD. (BOHECO)
Eligibility
Inclusion criteria
Inclusion criteria: 1) Adult subjects aged 18 years or older, with a confirmed diagnosis of cancer, at the time of screening. 2) Male and Female subjects (Females who are Non pregnant, non-lactating or with Menopause with more than 12 months) 3) Female subjects of childbearing potential practicing an acceptable method of birth control such as Intrauterine Device, oral contraceptive, transdermal, injection or implants, non hormonal or hormonal etc. in place prior to the start of the study and remaining in place during the study period OR Subjects who shall be practicing abstinence shall agree to have a documented second acceptable method of birth control should the subject become sexually active during the course of the study participation for the duration of the study as judged by the investigator(s)/study physician and agree to follow the same should be used during treatment. OR Postmenopausal for at least 1 year OR surgically sterile (bilateral tubal ligation/bilateral oophorectomy/hysterectomy has been performed on the subject) 4) Average pain intensity score in past 24 hours or current level of pain more than equal to 2.0 on a 0 to 10 point Numeric Rating Scale (NRS) 5) Karnofsky Performance Status Scale (KPS) score of 50 or greater (range 60-90). (Refer Appendix 10) 6) Subjects with Uncontrolled Pain and not responding to analgesics like Paracetamol OR other NSAIDS OR mild opioids like Tramadol 7) Individuals with an estimated life expectancy of more than 6 months. 8) Participant medically suitable to participate in the study intervention, as determined by the Principal Investigator (PI) based on clinical judgment 9) Willing to provide consent to the study and able to read and write in English or the local language.
Exclusion criteria
Exclusion criteria: 1) Subjects with significant cognitive impairment as determined by the clinical judgment of the investigator. 2) Individuals with a pre-existing non-cancer pain condition. 3) Subjects experiencing severe emotional distress in the opinion of principal investigator. 4) Individuals hospitalized 2 weeks before the date of ICF. 5) Individuals experiencing light headedness, inability to keep down food or fluids, or vomiting 6) Unwillingness to participate in all of the intervention sessions. 7) Subjects with glioblastoma or symptomatic brain metastases will be excluded. However, asymptomatic brain metastasis cases may be included at the discretion of the Principal Investigator (PI). 8) Subject had cancers affecting the oral cavity; radiotherapy to the floor of the mouth. Patients who had received therapies expected to confound the study outcome (epidural analgesia within 48 hours of screening; palliative radio, chemo, or hormonal therapy within two weeks of screening; or CBs within seven days of randomization) 9) Subjects taking levodopa, sildenafil, or subjects with hypersensitivity to CBs were excluded on safety grounds. 10) Baseline use of morphine at more than 500 mg morphine equivalents/day (inclusive of maintenance and breakthrough opioids), current use of more than one type of breakthrough opioid analgesic, planned clinical interventions that would affect pain, and any history of schizophrenia or substance abuse. 11) Subjects with a major psychiatric or cardiovascular disorder, epilepsy, or significant renal or hepatic impairment, or if they were pregnant, lactating or not using adequate contraception. 12) Subjects who are receiving or who were due to receive therapies that were expected to change the pain (such as radiotherapy, or chemotherapy or hormonal therapy) 13) Subjects who are using or had used marijuana, cannabinoid-based medications or rimonabant within 30 days of study entry and are unwilling to abstain for the duration of the study. 14) Subjects with previous medical history of arrhythmia 15) Any other conditions as decided by PI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To investigate the safety and tolerability of oral BOHECO COMBAT tincture. 2. To assess the efficacy of oral BOHECO COMBAT tincture as an Adjunctive Therapy in Cancer Patients whose pain is inadequately controlled with standard treatment (incl Paracetamol, mild opioids and NSAIDS) Timepoint: Baseline through End of study | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of BOHECO COMBAT in reducing pain intensity in cancer patients whose pain is inadequately controlled with standard treatment (incl Paracetamol, mild opioids and NSAIDS)Timepoint: Baseline through End of study;To evaluate reducing emotional parameters in cancer patients whose pain is inadequately controlled with standard treatment (incl Paracetamol, mild opioids and NSAIDS)Timepoint: Baseline (Day 0), Visit 6, and End of study;To evaluate sleep quality in cancer patients whose pain is inadequately controlled with standard treatment (incl Paracetamol, mild opioids and NSAIDS).Timepoint: Baseline (Day 0), Visit 2, Visit 3, Visit 6, and End of study;To evaluate change in reducing gastrointestinal symptoms in cancer patients whose pain is inadequately controlled with standard treatment (incl Paracetamol, mild opioids and NSAIDS).Timepoint: 1. Gastrointestinal symptom rating scale [Baseline (Day 0), Visit 6, and EOS] 2. Hunger Satiety Scale4[Baseline through End of study];To evaluate change in total analgesic consumption in cancer patients whose pain is inadequately controlled with standard treatment (incl Paracetamol, mild opioids and NSAIDS).Timepoint: 1. Change in total analgesic consumption[Baseline (Day 0), Visit 2, Visit 3, Visit 6 and end of study] 2. Change in Morphine equivalence[Baseline (Day 0), Visit 6, and end of study];To evaluate change in quality of life in cancer patients whose pain is inadequately controlled with standard treatment (incl Paracetamol, mild opioids and NSAIDS).Timepoint: Baseline (Day 0), Visit 6, and end of study;To evaluate change in patient-reported satisfaction with BOHECO COMBAT in cancer patients whose pain is inadequately controlled with standard treatment (incl Paracetamol, mild opioids and NSAIDS)Timepoint: Baseline (Day 0), Visit 6, and end of study ;To evaluate the change in level of addiction in cancer patients whose pain is inadequately controlled with standard treatment (incl Paracetamol, mild | — |
Countries
India
Contacts
Public ContactYeshi
BOMBAY HEMP COMPANY PVT. LTD. (BOHECO)
Outcome results
None listed