Health Condition 1: R688- Other general symptoms and signs
Conditions
Interventions
Intervention1: Group 1 (Shatavari)
: One 450 mg Shatavari (AR 25) Extract Capsule once daily after breakfast with water for 60 days.
Intervention2: Group 2 (Ashwagandha): One 450 mg Withania somnifera
Sponsors
Nisarga Biotech Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and females of age between18 to 45 years 2. Participants with body mass index (BMI) between 18.5 and 34.9 kg/m ; 3. Generally healthy, no diagnosis of uncontrolled chronic diseases (e.g., diabetes, thyroid disease, autoimmune disorders); 4. For Women only: Self-reported concerns suggestive of hormonal imbalance, including at least two of the following for at least 3 consecutive cycles: 1.Irregular menstrual cycles (cycle length less than 21 or more than 35 days) 2.Mood swings, irritability, low energy or fatigue 3.Hormonal acne or skin issues 4.Breast tenderness, bloating, or fluid retention 5.Hair thinning or increased hair fall 6.Sleep disturbances 5. For Men only: Self-reported symptoms suggestive of reduced testosterone levels, such as at least 2 of the following persisting for at least 6 weeks: 1.Reduced energy or motivation 2.Decreased libido or interest in sex 3.Mild erectile concerns (without ED diagnosis) 4.Mood changes or irritability 5.Low stamina or poor recovery post-exercise 6.Poor sleep or fatigue 7.Decreased muscle tone or loss of strength 6. No use of hormonal medications (e.g., contraceptives, steroids, hormone replacement therapy) in the last 3 months; 7. Willingness to maintain stable diet, sleep, and activity levels throughout the study duration; 8. Willing and able to give written informed consent and comply with study procedure.
Exclusion criteria
Exclusion criteria: 1. Diagnosed PCOS/PCOD, endometriosis, thyroid dysfunction, premature ovarian insufficiency, or other reproductive/endocrine disorders, hypogonadism, testosterone deficiency syndrome (TDS), or pituitary/adrenal disorders; 2. Pregnant, breastfeeding, or planning to conceive during the study period 3. Current use of hormonal contraceptives, hormone replacement therapy, or steroids; 4. Use of herbal/nutraceutical/hormonal supplements targeting hormonal health in the past 1 month; 5. History of major psychiatric illness (e.g., bipolar disorder, major depressive disorder); 6. Any major uncontrolled medical condition (e.g., hypertension, diabetes, liver/kidney disease); 7. Smoking, alcohol abuse, or recreational drug use; 8. Participation in another clinical study within the past 3 months; 9. Any condition that, in the investigator s opinion, may interfere with the study or pose risk to the participant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in hormonal levels at screening and day 60: For women: Estradiol, Progesterone, FSH, LH For men: Total Testosterone For both: salivary cortisol, salivary DHEA 2. Change in perceived energy levels via the Fatigue Severity Scale (FSS) at screening, day 30 and day 60. 3. Change in overall quality of life (QoL) using using World Health Organization Quality of Life Brief (WHOQOL-BREF) at screening and day 60. 4. Change in inflammatory biomarkers such as hs-CRP, ESR at screening and day 60. 5. Change in Profile of Mood Status (POMS) score at screening, day 30 and day 60. Timepoint: screening, day 30 and day 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in hematological and biochemical safety labs, complete blood count (CBC), liver function test (LFT), renal function test (RFT) at screening and day 60. 2. Change in vital signs at screening, baseline, day 30 and day 60. 3. Adverse events profile at baseline, day 30, and day 60. 4. Compliance and tolerability of the investigational product day 30, and day 60.Timepoint: screening, day 30 and day 60 | — |
Countries
India
Contacts
Public ContactMr Girish Soman
Nisarga Biotech Pvt Ltd
Outcome results
None listed