Trials / Completed
CompletedNCT03567798
Thrombocytopenia Induced by Chemotherapy
A Post Marketing Randomized Placebo Controlled Study to Evaluate the Efficacy of Study Product UPLAT® (Carica Papaya Leaf Extract + Tinospora Cardifolia Extract) in the Cancer Patients With Thrombocytopenia Induced by Chemotherapy
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Socrates School Of Health · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Not accepted
Summary
Single blind, randomized, multicentric placebo controlled study to evaluate the efficacy of Study product in patient with Chemotherapy induced thrombocytopenia. The Study is divided into \[screening visit (visit 1) \> baseline and treatment allocation visit (visit 2) \>blood collection (visit 3); treatment compliance visit (visit 4) \> blood collection (visit 5) \>blood collection (visit 6)\>end of study visit (visit 7)\].
Detailed description
UPLAT® (Carica papaya leaf Extract + Tinospora cardifolia Extract), is an orally administered dietary supplement for management of thrombocytopenia. Manufactured bySanat Products Ltd. Throughout study, it will be designated as product A to maintain study blindness at subject end. Placebo Throughout study, it will be designated as product B to maintain study blindness at subject end. Single blind, randomized, multicentric placebo controlled study to evaluate the efficacy of Study product in patient with Chemotherapy induced thrombocytopenia. The Study is divided into \[screening visit (visit 1) \> baseline and treatment allocation visit (visit 2) \>blood collection (visit 3); treatment compliance visit (visit 4) \> blood collection (visit 5) \>blood collection (visit 6)\>end of study visit (visit 7)\]. Dose regimen After meeting the inclusion criteria subject will take 4 units daily (2 in morning and 2 in evening) for 10 days. Patients will be called on Day5th, 10th and 15thfor the Complete blood count (Central lab). Total blood loss Approximately 8-12 mL
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | UPLAT | Carica papaya leaf Extract + Tinospora cardifolia Extract |
| OTHER | Placebo | Placebo |
Timeline
- Start date
- 2017-07-18
- Primary completion
- 2017-11-20
- Completion
- 2017-11-20
- First posted
- 2018-06-26
- Last updated
- 2018-06-27
Locations
1 site across 1 country: India
Source: ClinicalTrials.gov record NCT03567798. Inclusion in this directory is not an endorsement.