Clinical trial NCT05563064: Effect of Herbal Formulation on Thrombocytes Count
Official title: Effect of Herbal Formulation on Karika Syrup on Thrombocytes Count
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Thrombocytopenia
Keywords: Thrombocyte Count, Karika
Lead sponsor: Shifa Ul Mulk Memorial Hospital
Sponsor class: OTHER
First posted: 2022-10-03
Enrollment: 72
Sex: ALL
Minimum age (years): 14
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A randomized, open, prospective, multicenter clinical trial to evaluate the effects of Karika syrup on complete blood count specifically thrombocytes (platelets)
Primary purpose: TREATMENT

Brief summary: Effect of Herbal Formulation Karika Syrup on Thrombocyte Count.

Detailed description: In this study, we will evaluate the effect of Herbal Formulation Karika (composed of Carica papaya leaf extract and Tinosporacordifolia) on Complete Blood Count, specifically on Platelet Count. Low Platelet Count is highly observant during multiple diseases namely dengue, malaria, typhoid, chikungunya, viral infections, and other Diseases.

The proposed study is a randomized, open, prospective, multicenter clinical trial. Extracts found in Karika syrup are beneficial in escalating platelet count, and also have anti-inflammatory and antipyretic activity. The therapeutic indication of Karika is proven through this clinical study in patients with low platelet count associated with dengue, typhoid, malaria, viral fever, and chikungunya fever.

Dengue is a tropical disease caused by the RNA virus which resides in mosquitoes. Symptoms include high-grade fever, visual disturbances, pain in the eyes and head, nausea, vomiting, musculoskeletal pain, stiffness of joints, mild to moderate and severe bleeding, and sometimes puerperal rash appearing on the skin due to a deficiency of thrombocytes.

The Chikungunya virus is spread by the bite of an infected mosquito. Typhoid is caused by Salmonella typhi a bacterium. Typhoid fever symptoms are seen widely in the human body that may observe from relatively minor cases of diarrhea with low-grade fever to high-grade fever and profound diarrhea with involvement of multiple systems.1

Eligibility criteria: Inclusion Criteria:

* Inclusion Criteria:

  1. Female and Male patients of age 14 to 60 years.
  2. Patient suffering from complaints of Weakness, Fatigue, Puerperal Rashes, Shortness of Breath, Low Hemoglobin, and History of Fever on \& off, Epistaxis.18
  3. Patients from Karachi and Kapri Mori(Labors, Employed, Multigravida females, Housewives, Domestic helpers, Working women, School, College, and University Students).
  4. All socioeconomic classes are included in the study.
  5. Patients having a history of Covid-19, Viral fever, Typhoid, and other illnesses in which there has been a low platelet count.2

Exclusion Criteria:

* Exclusion Criteria:

  1. Pregnant females are excluded.17
  2. Patients with co-morbidities like uncontrolled hypertension and liver disorder are excluded.4,5,6
  3. Patient having known drug reaction from any content of formulation is excluded.7
  4. Patients suffering from serious illnesses like encephalitis, coma, meningitis, or head injury that make them bedridden or hospitalized are excluded.4,6

Primary outcomes:
measure: EFFECT OF HERBAL FORMULATION KARIKA SYRUP ON THROMBOCYTE COUNT
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Pakistan
state: Sindh
Study officials:
References: