A Clinical study of Shalmalyadi ghrita orally and Shalmalyadi ghrita Pichu in the patients of Asrigdara.

Phase 2

Not yet recruiting

• Conditions: Abnormal uterine and vaginal bleeding, unspecified. Ayurveda Condition: ASRUGDARAH/RAKTAPRADARAH,

• Registration Number: CTRI/2023/09/057997
• Lead Sponsor: State Ayurvedic college and Hospital Lucknow

Brief Summary

**Subject of the tittle**-A Comparative clinical study to evaluate the efficacy of Shalmalyadi Ghrita Orally & Shalmalyadi Ghrita Pichu in the management of Asrigdara with special reference to Dysfunctional Uterine Bleeding.

**Objective of the Study**- To compare the efficacy of Shalmalyadi Ghrita Pichu and Shalmalyadi Ghrita Pichu along with oral intake in the management of Asrigdara w.s.r to Dysfunctional Uterine bleeding.

**Type of study**-Randomized open level parallel clinical trial.

**Administration of trial therapy**-

**Sample size**- Minimum 40 patients.

**Group A-** –In this group patients will be treated with SHALMALYADI GHRITA 6 g BD orally with anupan of lukewarm water after meals and SHALMALYADI GHRITA SOAKED PICHU locally kept in the vagina for 7 days after cessation of menstrual cycle .

**Group B-** In this group patients will be treated with SHALMALYADI GHRITA SOAKED PICHU locally kept in the vagina for 7 days after cessation of menstrual cycle.

**Duration of Trial**– 3 Months

**Follow up during treatment** – after each menstrual cycle for 3 consecutive months.

**Follow up After Treatment:**- On the clearance of next one successive menstrual cycle after completion of trial.

**DIAGNOSTIC CRITERIA**

Diagnosis of each case will be made with the help of detailed history in respect to disease, family history, previous similar episode, physical and systemic examination as well as the investigation.

**SUBJECTIVE DIAGNOSTIC PARAMETERS**

Cardinal Symptoms of Asrigdara

•Amount of menstrual bleeding

•Duration of Menstrual cycle

•Interval of Menstrual cycle

•Passage of clots during menstruation

•Pain during menstruation

**OBJECTIVE CRITERIA**: Hb%,

**INCLUSION CRITERIA**: -

➢Adult married female who are in age group of 20-45years.

➢Patient willing for trial.

➢Patients simultaneously diagnosed with cardinal symptoms of Asrigdara / DUB (Excessive, prolonged and intermenstrual bleeding) .

**EXCLUSION CRITERIA**: -

➢Patients below 20 yrs and above 45 yrs.

➢Patients with Post menopausal bleeding

➢Patients with Hb less than 8 %

➢Patient with any other pelvic pathology(chronic cervicitis , fibroid and malignancy)

➢Patient on oral contraceptives, or using intrauterine contraceptive devices.

➢Patients with systemic diseases (diabetes mellitus, tuberculosis, jaundice, severe HTN).

➢VDRL, HIV, HBsAg positive patient.

➢Patients having coagulation disorders.

**LABORATORY INVESTIGATIONS**

1.Estimation of Hb%, TLC, DLC, ESR.

2.BT & CT

3.RBS

4.Urine examination (routine & microscopic)

5.TSH

6.LFT

7.KFT

8.USG

**ASSESSMENTCRITERIA**: -

The improvement will be assessed on the basis of relief in the sign and symptomsymptoms for the purpose.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-10
• Last Update Posted: 2023-12-09

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• 1.Adult married female who are in age group of 20-45years.
• 2.Patient willing for trial.
• 3.Patients simultaneously diagnosed with cardinal symptoms of Asrigdara / DUB (Excessive, prolonged and intermenstrual bleeding) .

Exclusion Criteria

• 1.Patients below 20 yrs and above 45 yrs.
• 2.Patients with Post menopausal bleeding 3.Patients with Hb less than 8 % 4.Patient with any other pelvic pathology(chronic cervicitis , fibroid and malignancy) 5.Patient on oral contraceptives, or using intrauterine contraceptive devices.
• 6.Patients with systemic diseases (diabetes mellitus, tuberculosis, jaundice, severe HTN).
• 7.VDRL, HIV, HBsAg positive patient.
• 8.Patients having coagulation disorders.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. To assess the efficacy of trial therapy on subjective parameters like Amount of menstrual bleeding, Duration of Menstrual cycle, Interval of Menstrual cycle , Passage of clots during menstruation, Pain during menstruation.	2 months

Secondary Outcome Measures

Name	Time	Method
1.To assess the efficacy of trial therapy on subjective parameters like Amount of menstrual bleeding, Duration of Menstrual cycle, Interval of Menstrual cycle , Passage of clots during menstruation, Pain during menstruation.

Trial Locations

Locations (1)

State Ayurvedic College and Hospital Lucknow; 🇮🇳 Lucknow, UTTAR PRADESH, India

State Ayurvedic College and Hospital Lucknow

🇮🇳Lucknow, UTTAR PRADESH, India

Dr Nishika kaushal

Principal investigator

9411800551

kaushalnishi1915@gmail.com