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To study the role of Eladi Kwatha with Sharkara and Madhu in atyadhik yonigata raktastrava with special reference to Abnormal uterine bleeding

Not yet recruiting
Conditions
Endocrine disorder, unspecified. Ayurveda Condition: Yonipravaha (Abnormal Uterine Bleeding),
Registration Number
CTRI/2021/05/033360
Lead Sponsor
Kalyani Mitalkumar Mahajan
Brief Summary

TITLE - An open label single arm clinical study of Eladi Kwatha with Sharkara and Madhu in Yonipravaha with special reference to abnormal uterine bleeding

Study design - an open label single arm clinical study

SAMPLE SIZE - 30

SAMPLING METHOD - Sequential Sampling



INCLUSION CLITERIA -Patients between the age group 15-45 yrs

Both married and unmarried women

Patients having Abnormal Uterine Bleeding with excessive and prolonged menstrual bleeding



EXCLUSION CLITERIA - Patients taking anti coagulation therapy and having any coagulation defect.

Patients with severe malnutrition and severe anemia (Hb ≤ 8 gm/dl).

Threatened, spontaneous or incomplete abortion/ectopic pregnancy,

trophoblastic diseases, placental abnormalities and Antepartum Hemorrhage.

Patients with systemic diseases like uncontrolled D.M. and T.B.

History of documented vascular disease like coronary artery disease,

cerebrovascular disease or stroke, transient ischemic attack, peripheral

vascular disease and DVT.

Condition like endometrial cancer of cervix, etc.

Bleeding from Reproductive Track due to traumatic causes, motor vehicle

accident and IC



WITHDRAWAL CLITERIA -  Patients not willing for further trial.

- If patient develops any adverse effect.

- If bleeding increases during trial.

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
Female
Target Recruitment
30
Inclusion Criteria

Patients between the age group 15-45 yrs Both married and unmarried women Patients having Abnormal Uterine Bleeding with excessive and prolonged menstrual bleeding.

Exclusion Criteria
  • Patients taking anti coagulation therapy and having any coagulation defect.
  • Patients with severe malnutrition and severe anemia (Hb ≤ 8 gm/dl).
  • Threatened, spontaneous or incomplete abortion/ectopic pregnancy, trophoblastic diseases, placental abnormalities and Antepartum Hemorrhage.
  • Patients with systemic diseases like uncontrolled D.M. and T.B. History of documented vascular disease like coronary artery disease, cerebrovascular disease or stroke, transient ischemic attack, peripheral vascular disease and DVT.
  • Condition like endometrial cancer of cervix, etc.
  • Bleeding from Reproductive Track due to traumatic causes, motor vehicle accident and IC.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To study the efficacy of Eladi Kwatha with Sharkara and Madhu inday 1 to day 5 of Abnormal uterine bleeding
Yonipravaha.day 1 to day 5 of Abnormal uterine bleeding
Secondary Outcome Measures
NameTimeMethod
Adverse effect of drug Eladi Kwatha with Sharkara and Madhu will beobserved during clinical study, if any.

Trial Locations

Locations (1)

Sane Guruji Arogya Kendra

🇮🇳

Pune, MAHARASHTRA, India

Sane Guruji Arogya Kendra
🇮🇳Pune, MAHARASHTRA, India
Dr Kalyani Mitalkumar Mahajan
Principal investigator
8983460329
mkrushna002@gmail.com

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