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Effect of Herbal Formulation on Thrombocytes Count

Primary Purpose

Thrombocytopenia

Status
Recruiting
Phase
Phase 3
Locations
Pakistan
Study Type
Interventional
Intervention
Karika Syrup
Sponsored by
Shifa Ul Mulk Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thrombocytopenia focused on measuring Thrombocyte Count, Karika

Eligibility Criteria

14 Years - 60 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • PakistanRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Karika Syrup

Arm Description

Karika syrup has been used to treat thrombocytopenia

Outcomes

Primary Outcome Measures

EFFECT OF HERBAL FORMULATION KARIKA SYRUP ON THROMBOCYTE COUNT
This study is designed to check or confirm the Karika syrup efficacy for increasing the platelet count, its anti-inflammatory and anti-pyretic actions. This medicinal use of Karika will be confirmed through clinical studies in patients with low platelet count associated with dengue, typhoid, malaria, viral fever& chikungunya fever.9 It is based on the interpretations as generated from CBC by analyzing it on SPSS. 10 It is research-based open, randomized clinical trial on 72 subjects Multi-centered: Karachi (Kalaboard, Jafar-e-tyyar) and Interior Sindh (Kapri Mori).

Secondary Outcome Measures

Full Information

First Posted
September 28, 2022
Last Updated
October 1, 2022
Sponsor
Shifa Ul Mulk Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05563064
Brief Title
Effect of Herbal Formulation on Thrombocytes Count
Official Title
Effect of Herbal Formulation on Karika Syrup on Thrombocytes Count
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
January 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shifa Ul Mulk Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombocytopenia
Keywords
Thrombocyte Count, Karika

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
A randomized, open, prospective, multicenter clinical trial to evaluate the effects of Karika syrup on complete blood count specifically thrombocytes (platelets)
Masking
None (Open Label)
Allocation
N/A
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Karika Syrup
Arm Type
Experimental
Arm Description
Karika syrup has been used to treat thrombocytopenia
Intervention Type
Drug
Intervention Name(s)
Karika Syrup
Intervention Description
To evaluate the effects of Karika syrup on complete blood count specifically thrombocytes (platelets) collected from blood samples of patients after treatment of 15 days long period.
Primary Outcome Measure Information:
Title
EFFECT OF HERBAL FORMULATION KARIKA SYRUP ON THROMBOCYTE COUNT
Description
This study is designed to check or confirm the Karika syrup efficacy for increasing the platelet count, its anti-inflammatory and anti-pyretic actions. This medicinal use of Karika will be confirmed through clinical studies in patients with low platelet count associated with dengue, typhoid, malaria, viral fever& chikungunya fever.9 It is based on the interpretations as generated from CBC by analyzing it on SPSS. 10 It is research-based open, randomized clinical trial on 72 subjects Multi-centered: Karachi (Kalaboard, Jafar-e-tyyar) and Interior Sindh (Kapri Mori).
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Inclusion Criteria: Female and Male patients of age 14 to 60 years. Patient suffering from complaints of Weakness, Fatigue, Puerperal Rashes, Shortness of Breath, Low Hemoglobin, and History of Fever on & off, Epistaxis.18 Patients from Karachi and Kapri Mori(Labors, Employed, Multigravida females, Housewives, Domestic helpers, Working women, School, College, and University Students). All socioeconomic classes are included in the study. 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: Pregnant females are excluded.17 Patients with co-morbidities like uncontrolled hypertension and liver disorder are excluded.4,5,6 Patient having known drug reaction from any content of formulation is excluded.7 Patients suffering from serious illnesses like encephalitis, coma, meningitis, or head injury that make them bedridden or hospitalized are excluded.4,6
Facility Information:
Facility Name
Pakistan
City
Karachi
State/Province
Sindh
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Halima Nazar, Ph.D
Phone
03322889976
Email
halimanazar76@gmail.com
First Name & Middle Initial & Last Name & Degree
Shayan Fatima

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Effect of Herbal Formulation on Thrombocytes Count

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