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Clinical Trials/CTRI/2024/12/078002
CTRI/2024/12/078002Not yet recruitingPhase 2

RANDOMIZED CONTROLLED CLINICAL TRIAL TO DETERMINE THE EFFECT OF ATIBALA CHURNA (ABUTILON INDICUM) IN THE MANAGEMENT OF RAKTAPRADARA W.S.R ABNORMAL UTERINE BLEEDING

Dr shabanuri wahid khan1 site in 1 country60 target enrollmentStarted: December 30, 2024Last updated:

Trial Snapshot

Phase
Phase 2
Status
Not yet recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
To determine the efficacy of Atibala Churna in the management of Raktapradara with special reference to Abnormal Uterine Bleeding.

Study Overview

Brief Summary

Raktapradara is a considerable health care burden for a woman and has a definite effect on her quality of life. It is said presently only hormones, prostaglandin synthesis inhibitors (PSI) and antifibrinolytic agents are available for this condition; these have their own side effects. AUB leads to loss of productivity and may result in surgical interventions including hysterectomy. Thus, to overcome above raised problems in present dissertion study of Atibala Churna is taken in the management of Raktpradara w.s.r to Abnormal uterine bleeding. Atibala Churna is easily available, cost effective and affordable for patient. This study is A  “RANDOMIZED CONTROLLED CLINICAL TRIAL TO DETERMINE THE EFFECT OF ATIBALA CHURNA (ABUTILON INDICUM) IN THE MANAGEMENT OF RAKTAPRADARA W.S.R. TO ABNORMAL UTERINE BLEEDING”.  In this study Randomly 60 patients having signs and symptoms of Raktapradara will be selected from OPD and IPD of sst  Ayurved Ruganalaya. They will be divided in Group A and Group B accordingly (Group A Trial - Atibala Churna with Madhu, Group B control - Yashtimadhu Churna with Madhu). 30 patients in each group will be studied. study will be conducted in India. Outcome of study will be asses on reducing symptoms of raktapradara like Raja ati pravrutti, deergha kala artava pravruttti, shroni prustha kukshi shoola

Study Design

Study Type
Interventional
Allocation
Other
Masking
None

Eligibility Criteria

Ages
16.00 Year(s) to 45.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • Patients having symptoms of Raktpradara i.e 1.Raja Ati Pravrutti (Excessive menstrual bleeding i.e more than 3 pads/day).
  • 2.Deergha Kala Artava Pravrutti.
  • (Menstrual bleeding that last for more than 7 days).
  • 3.Daha in Adho Vankshana (Burning sensation in groin region).
  • 4.Shroni, Prushtha and Kukshi shoola (Pain during menstruation).
  • Hb percentage above 7 gm %.

Exclusion Criteria

  • Known patients suffering with uterine & pelvic pathology like Uterine fibroid, Adenomyosis, Polyp, Pelvic inflammatory disease, Post-menopausal bleeding, etc.
  • Known patient with any serious systemic disorder like HTM, DM, TB, Thyroid etc.
  • K/C/O Abortion/ ectopic pregnancy.
  • K/C/O PCOD & Other related disease.
  • Patients with IUCD and on OCP pills.
  • Patient taking Anti-coagulation therapy and having any coagulant defects like Thrombocytopenic Purpura.

Outcomes

Primary Outcomes

To determine the efficacy of Atibala Churna in the management of Raktapradara with special reference to Abnormal Uterine Bleeding.

Time Frame: 90 days

Secondary Outcomes

  • Hemoglobin percentage will be observed(before treatment & after completion of treatment)

Investigators

Sponsor
Dr shabanuri wahid khan
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dr shabanuri wahid khan

Sangam Sevabhavi Trust Ayurved Medical College Sangamner

Study Sites (1)

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