PLAT, a herbal treatment for reduced platelet count after chemotherapy
- Conditions
- Health Condition 1: D695- Secondary thrombocytopenia
- Registration Number
- CTRI/2021/09/036685
- Lead Sponsor
- Sanat Products Ltd a part of Dr Willmar Schwabe India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria for CIT groups
1. Male or female aged between 18-65 years.
2. Subjects willing to sign an informed consent with date prior to participation in the trial.
3. Patients with confirmed solid tumor and received at least one cycle of chemotherapy prior to screening visit.
4. Patients with a platelet counts between > 40000 and < 120,000/ml at the time of screening.
Inclusion criteria For Prophylaxis group:
1. Male or female aged between 18-65 years.
2. Subjects willing to sign an informed consent with date prior to participation in the trial.
3. Patients with confirmed solid tumor and received at least one cycle of chemotherapy prior to screening visit and with
history of CIT during any previous cycle of chemotherapy
Exclusion Criteria for CIT groups
1.Pregnant or lactating women.
2.Subjects planning to receive any type of surgery.
3.Patients with platelet count less than 30000/ml.
4.Patients with thrombocytopenia presenting with active bleeding.
5.Patients who have received blood or blood product transfusion during the current illness or during past one week.
6.Patients with thrombocytopenia purpura (ITP) leukemia, hemophilia or bleeding diathesis.
7.Participation in another trial with another investigational product
Exclusion criteria For Prophylaxis group:
1.Planning to receive any type of surgery.
2. Pregnant or lactating women.
3. Patients with thrombocytopenia presenting with active bleeding.
4. Patients who have received blood or blood product transfusion during the current illness or during past one week.
5. Patients with thrombocytopenia purpura (ITP) leukemia, hemophilia or bleeding diathesis.
6. Participation in another trial with another investigational product
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in platelet count <br/ ><br>after chemotherapy <br/ ><br> <br/ ><br>% reduction in number of CIT cases as compared to previous cycleTimepoint: days 0, 7, 10 and 14
- Secondary Outcome Measures
Name Time Method Hb%, TLC, DLC, Bilirubin, SGOT <br/ ><br>SGPT, ALP, Urea, Creatinine <br/ ><br>Timepoint: Days 0, 7, & 14