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Clinical Trials/CTRI/2023/07/055880
CTRI/2023/07/055880Not yet recruitingPhase 2

A Randomized Open-Labelled Controlled Clinical Study To Evaluate The Efficacy Of Udumbara Kashaya Yoni Prakshalana In Shweta Pradara w.s.r To Vaginitis.

Dr AFREEN KOUSAR ALI1 site in 1 country30 target enrollmentStarted: October 8, 2023Last updated:

Trial Snapshot

Phase
Phase 2
Status
Not yet recruiting
Sponsor
Enrollment
30
Locations
1
Primary Endpoint
Complete reduction in white discahrge

Study Overview

Brief Summary

• Shweta Pradara is a Kaphaja disorder in region of Apana Vayu, as a type of Srava which is resulted from Kapha Dosha. It is a symptom and disease itself of Stree Rogas that occur due to vitiation of Kapha.

• It is characterized by subject showing classical symptom of Shweta Pradara with or without pruritus, foul smell, associated with problems like low back pain, lower abdomen pain, mental stress, sexual anxiety and local discomfort.

•The white discharge may start as a simple problem and may lead to pelvic inflammatory diseases, menstrual irregularities, infertility and other obstetric complications like premature labor, PROM, intrauterine infection and perinatal complications.

•The term Vaginitis is the diagnosis given to women who complain of abnormal vaginal discharge with vulvar burning, irritation, or itching. It is one of the most frequent reasons for patient visits to the gynecologist.

•Yoni Prakshalana is a cleansing procedure which helps in removing the excessive and abnormal vaginal discharges along with harmful microorganisms, by promoting new tissue growth, thus heals unhealthy vaginal mucosa, reduces the inflammation and congestion in order to maintain the normal vaginal flora.

• Yoni Prakshalana with Udumbara Kashaya is expecting to give beneficial results in Shweta Pradara and hence it is taken up for this study.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
Open Label

Eligibility Criteria

Ages
20.00 Year(s) to 40.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • Subjects between the age group of 20-40 years.
  • Subjects willing for Per speculum and Per vaginal examination.
  • Married woman.
  • Subjects presenting classical symptoms of Shwetha Pradara.
  • Subjects with the classical symptoms of Vaginitis.
  • Subjects willing to sign the consent form.

Exclusion Criteria

  • Unmarried women.
  • Women below 20 years and above 40 years.
  • Pregnant woman.
  • Subject with known case of Benign and Malignant tumors.
  • Subject with known case of PID.
  • Subject with known case of Cervicitis.
  • Subject with known case of Systemic disorders.
  • Subject with known case of STDs (Syphilis, Chlamydia, Gonorrhea).

Outcomes

Primary Outcomes

Complete reduction in white discahrge

Time Frame: Before treatment 0th day | After treatment 7th day | Follow up 15th day

Secondary Outcomes

  • Reduction in itching, burning micturition, backache, foul smell in discharge(Before treatment 0th day)

Investigators

Sponsor
Dr AFREEN KOUSAR ALI
Sponsor Class
Other [self]

Study Sites (1)

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