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A Pharmaceutico-Analytical and Clinical study ofSaubhagyadi Gutika on Pain during menstruatio

Not Applicable
Completed
Conditions
Health Condition 1: N944- Primary dysmenorrhea
Registration Number
CTRI/2021/03/032166
Lead Sponsor
State Ayurvedic College and Hospital Lucknow
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
30
Inclusion Criteria

1. Patients who are suffering from primary dysmenorrheal.

2. Patient comes with chief complaint of pain during menses along with associated

symptoms.

3. Patients within the age group 18-40 years.

4. Patients suffering for more than 3 consecutive cycles.

5. Patient with H/O using analgesics and other drug during menses.

Exclusion Criteria

1.Patients below 18 and above 40 years of age.

2. Patients suffering from secondary dysmenorrhea; having organic pathology of uterus

and adenexa. e.g.- Fibroid uterus, carcinoma of endometrium, venereal diseases ,PID,

adenomyosis, endometriosis etc.

3. Patients suffering from systemic diseases.

4. Patient using intra uterine contraceptive devices.

5. Those under any hormonal therapy.

6. Patients having Pain abdomen associated with excessive bleeding p/v.

7. Patients with H/O thyroid dysfunction.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1.To assess the efficacy of Saubhagyadi Gutika <br/ ><br>2.To assess the efficacy of trial drug on subjective parameter severity of pain,duration of pain,site of pain, nature of painTimepoint: Final assessment will be done after completion of trial of four consecutive menstrual cycles.
Secondary Outcome Measures
NameTimeMethod
To assess the efficacy of trial drug on associated symptoms Praseka (Nausea),Chhardi (Vomiting),Vibandha (Constipation) ,Atisara (Diarrhea),Aruchi (Loss of <br/ ><br>appetite),Shrama (Fatigue),Shirashula (Headache),Vankshana Shula (tenesmus of the bladder), Kati Shula, <br/ ><br>and Janu Shula,Swedadikya (excessive sweating),Tamodarshana (Faints)Timepoint: Follow up- each menstrual cycle during trial.
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