A comparative clinical evaluation of shatpushpa shatavari churna and shatpushpa taila uttar vasti in the management of artava kshaya with special reference to oligohypomenorrhoea
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- To assess the efficacy of trial therapy on subjective parameters likeInterval between two cycles,
Study Overview
Brief Summary
Title - A comparative clinical evaluation of Shatpushpa - shatavari churna and Shatpushpa taila uttarbasti in the management of Artavakshaya wsr oligo- hypomenorrhoea.
Objective - To compare the efficacy of Shatpushpa - shatavari churna orally along with Shatpushpa taila uttarbasti in the management of Artavakshaya wsr oligo-hypomenorrhoea.
Type of study – Randomized comparative open clinical trial.
Administration of trial therapy – Minimum 40 patient having cardinal symptoms of Artavakshaya will be registered into two groups.
Group 1– This group of patients will be given the trial drug Shatpushpa- Shatavari Churna 5 gm with ghrita twice a day for 3 consecutive cycles after clearance of menses.
Group 2 – This group of patients will be given the trial drug Shatpushpa- Shatavari Churna 5 gm with ghrita twice a day along with Shatpushpa taila Uttarbasti 5 ml once a day for 3 alternate days for 3 consecutive cycles after clearance of menses.
Duration of trial – 4 consecutive cycles (3 cycles with trial drug and one cycle drug free Follow up).
Follow up during treatment – On the clearance of each menstrual cycle during the period of treatment.
CRITERIA FOR SELECTION OF PATIENT
Diagnostic Criteria-
Diagnosis will be based on the presence of any two or more of the cardinal symptoms of Artavakshaya.
A.Yathochitakala Adarshanam of Artava – Menstrual cycle > 35 days
B.Alpartavam – a) Duration of menstrual bleeding < 2 days
b) Decrease in quantity of menstrual blood (using 1-2 pads per day)
C.Yoni Vedana– Pain during menstruation
Inclusion criteria:
1.Married patients fulfilling the cardinal symptoms of Artavakshaya.
2.Patients between the age group of 20-40 years.
3.Patients willing to participate in the study with proper written consent.
Exclusion criteria:
1.Patient having systemic diseases which interfere with the present study.
2.Pregnant & Lactating women.
3.Patient on OCPs, IUCD.
4.Patient with congenital anomalies of uterus or ovaries.
5.Any other pelvic pathology or malignancy.
6.Anaemic patients (Hb less than 8 gm/dL)
Discontinuation Criteria:
1.Patient does not want to continue trial.
2.Aggravation of complaint
3.Any other acute illness.
Investigation: At the time of registration.
1.CBC
2.ESR
3.RBS
4.LFT
5.Thyroid profile
6.USG uterus and adnexa – TAS/TVS
7.UPT
8.LH , FSH (if needed)
ASSESSMENT CRITERIA
Assessment will be done on the basis of improvement in the sign and symptom for the purpose.
SUBJECTIVE CRITERIA
1.Interval between two cycles.
2.Duration of Menstrual Bleeding.
3.Amount of Menstrual blood loss.
4.Pain during Menstruation.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 20.00 Year(s) to 40.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •1.Married patients fulfilling the cardinal symptoms of Artavakshaya.
- •2.Patients between the age group of 20-40 years.
- •3.Patients willing to participate in the study with proper written consent.
Exclusion Criteria
- •1.Patient having systemic diseases which interfere with the present study.
- •2.Pregnant & Lactating women.
- •3.Patient on OCPs, IUCD.
- •4.Patient with congenital anomalies of uterus or ovaries.
- •5.Any other pelvic pathology or malignancy.
- •6.Anaemic patients (Hb less than 8 gm/dL).
Outcomes
Primary Outcomes
To assess the efficacy of trial therapy on subjective parameters likeInterval between two cycles,
Time Frame: 2 month
Duration of Menstrual Bleeding,Amount of Menstrual blood loss & Pain during Menstruation.
Time Frame: 2 month
Secondary Outcomes
- To assess the effect of trial therapy in the management of Artavakshaya.