A Comparative Clinical study of Shatvariyadi churna and Brahmi ghrita Nashya in the management of menopausal symptoms.

Phase 2

Conditions: Health Condition 1: N951- Menopausal and female climactericstates

Recruitment & Eligibility

Inclusion Criteria

1. Amenorrhea for 12 months or more.

2. women age group 45-60 years.

3. Women is not undergoing any estrogen replacement therapy presently and

also not for last 6 Months for menopausal symptoms.

4. Subjects taking medication for HTN, D.M, if she had, should be controlled.

5. Subjects fulfilling the inclusion criteria.

6. Subjects willing to participate in this trial.

Exclusion Criteria

1. Women with Surgical menopause.

2. Patient with evidence of Malignancy.

3. Patient with uncontrolled Diabetes Mellitus.

4. Patient who have a past history of Heart disease like Atrial Fibrillation , Coronary artery

disease (CAD), Acute coronary Syndrome ,MI , Stroke , Heart failure etc.

5. Patient with poorly controlled Hypertension.

6. Patient on prolonged medication ( >6 months) with Hormone Replacement Therapy

( HRT) corticosteroids , Antidepressant , etc or any other drugs that may have an

influence on the outcome of study.

7. Patient with concurrent serious hepatic disorders , Renal pathology.

8. Patient with severe Pulmonary Dysfunction .

9. Patient undergoing any kind of Chemotherapy , Radiotherapy.

10. Subjects who not willing to participate in the study

Primary Outcome Measures

Name	Time	Method
1.To evaluate the efficacy of Shatavariyadi churna with Brahmi ghrita nashya in management of Rajo niviritti janya laksana w.s.r to Menopausal syndrome. <br/ ><br> <br/ ><br>2.To assess the efficacy of trial therapy on the subjective parameters like Hot flushes, Nights sweats, Fatigue, Palpitation, Weakness ,Insomnia ,Irritability <br/ ><br> Anxiety, Mood swing, Depression and objective parameters are blood CBC ,RBS ,Urine â?? R/M, Thyroid profile, USG. <br/ ><br>Timepoint: Final assessment will be done after completion of trial of 4 consecutive months (3 months with clinical therapy and 1 month drug free) <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
To assess the efficacy of trial therapy on subjective parameters like Hot flushes, Nights sweats, Fatigue, Palpitation ,Weakness, Insomnia Irritability, Anxiety, Mood swing, Depression on the management of Menopausal syndrome. <br/ ><br>Timepoint: Follow up- Each month during trial.