Effect of Shatpushpa- Shatavari churna and Shatpushpa taila UB in Artavakshaya.

Phase 2

Recruiting

• Conditions: Oligomenorrhea, unspecified. Ayurveda Condition: ARTAVAKSHAYAH,

• Registration Number: CTRI/2023/09/057499
• Lead Sponsor: State ayurvedic college and hospital Lucknow

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-25
• Last Update Posted: 2023-09-29

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Female
• Target Recruitment: 40

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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the efficacy of trial therapy on subjective parameters likeInterval between two cycles,	2 month
Duration of Menstrual Bleeding,Amount of Menstrual blood loss & Pain during Menstruation.	2 month

Secondary Outcome Measures

Name	Time	Method
To assess the effect of trial therapy in the management of Artavakshaya.

Trial Locations

Locations (1)

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

State Ayurvedic College and Hospital

🇮🇳Lucknow, UTTAR PRADESH, India

Dr Sheetal Verma

Principal investigator

8957935355

sheetalverma1408@gmail.com