NCT05563064

Brief Summary

Effect of Herbal Formulation Karika Syrup on Thrombocyte Count.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 28, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 3, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

October 4, 2022

Status Verified

October 1, 2022

Enrollment Period

2 years

First QC Date

September 28, 2022

Last Update Submit

October 1, 2022

Conditions

Keywords

Thrombocyte Count, Karika

Outcome Measures

Primary Outcomes (1)

  • 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).

    3 years

Study Arms (1)

Karika Syrup

EXPERIMENTAL

Karika syrup has been used to treat thrombocytopenia

Drug: Karika Syrup

Interventions

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.

Karika Syrup

Eligibility Criteria

Age14 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pakistan

Karachi, Sindh, Pakistan

RECRUITING

MeSH Terms

Conditions

Thrombocytopenia

Condition Hierarchy (Ancestors)

Blood Platelet DisordersHematologic DiseasesHemic and Lymphatic DiseasesCytopenia

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: A randomized, open, prospective, multicenter clinical trial to evaluate the effects of Karika syrup on complete blood count specifically thrombocytes (platelets)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairperson Department of Eastern Medicine, Jinnah University

Study Record Dates

First Submitted

September 28, 2022

First Posted

October 3, 2022

Study Start

January 1, 2021

Primary Completion

January 1, 2023

Study Completion

January 1, 2023

Last Updated

October 4, 2022

Record last verified: 2022-10

Locations