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Effect of Herbal Formulation on Thrombocytes Count

Sponsor
Shifa Ul Mulk Memorial Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05563064
Collaborator
(none)
72
Enrollment
1
Location
1
Arm
24
Anticipated Duration (Months)
3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Effect of Herbal Formulation Karika Syrup on Thrombocyte Count.

Condition or Disease Intervention/Treatment Phase
  • Drug: Karika Syrup
 Phase 3

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
72 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
A randomized, open, prospective, multicenter clinical trial to evaluate the effects of Karika syrup on complete blood count specifically thrombocytes (platelets)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)
Primary Purpose:
Treatment
Official Title:
Effect of Herbal Formulation on Karika Syrup on Thrombocytes Count
Actual Study Start Date :
Jan 1, 2021
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Karika Syrup

Karika syrup has been used to treat thrombocytopenia

Drug: Karika Syrup
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.

Outcome Measures

Primary Outcome Measures

  1. EFFECT OF HERBAL FORMULATION KARIKA SYRUP ON THROMBOCYTE COUNT [3 years]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
14 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pakistan Karachi Sindh Pakistan

Sponsors and Collaborators

  • Shifa Ul Mulk Memorial Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr. Hafiz Muhammad Asif, Chairperson Department of Eastern Medicine, Jinnah University, Shifa Ul Mulk Memorial Hospital
ClinicalTrials.gov Identifier:
NCT05563064
Other Study ID Numbers:
  • Shayan Fatima
First Posted:
Oct 3, 2022
Last Update Posted:
Oct 4, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dr. Hafiz Muhammad Asif, Chairperson Department of Eastern Medicine, Jinnah University, Shifa Ul Mulk Memorial Hospital
Thrombocyte Count, Karika
Additional relevant MeSH terms:
Thrombocytopenia

Study Results

No Results Posted as of Oct 4, 2022