To check the effect of ashwagandha in improvement in stressful condition and energy level

A randomized, multi- centric, five arm, placebo and active controlled parallel group study to evaluate the adaptogenic, anti-stress, and immunity-enhancing effects of novel ashwagandha formulations in participants who are in stressful condition, have low immunity, energy level and chronic fatigue syndrome. - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/11/097700

Enrollment

Registered

2025-11-19

Start date

Unknown

Completion date

Unknown

Last updated

2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: R538- Other malaise and fatigue

Interventions

Intervention1: Ashwagandha Oil (ASOIL) Formulation: Composition: Ashwagandha extract 1.5% Withanolides Dosage: One capsule orally, once daily, for 14 days. Intervention2: Ashwagandha Powdered For

Eligibility

Inclusion criteria

Inclusion criteria: 1. Participants between 18 to 65 years 2. Moderate perceived stress score (Perceived Stress Scale (PSS) score greater than and equal to 14). 3. Self-reported or clinically observed frequent infections 4. Persistent fatigue for greater than and equal to 6 months not substantially alleviated by rest History of known CFS 5. Willingness to provide informed consent and comply with study protocol. 6. No use of Ashwagandha or adaptogenic supplements in past 30 days.

Exclusion criteria

Exclusion criteria: 1. Any other chronic illness like diabetes mellitus and hypertension 2.Signs and symptoms of any acute infections in the past 2 weeks. 3. Immunosuppressive or psychotropic medication use in the last month. 4. History of hypersensitivity to Ashwagandha or herbal supplements. 5. Pregnant or lactating women. 6. History of psychiatric illness, substance abuse, or sleep disorders. 7. Participation in another clinical study within the past 30 days. 8. History of drug or alcohol abuse during the last 6 months.

Design outcomes

Primary

Measure	Time frame
1. Change in Perceived Stress Scale (PSS) 2. Serum/salivary Cortisol Levels 3. Sleep Quality Assessment Pittsburgh Sleep Quality Index (PSQI). 4. Quality of Life SF-36 Timepoint: Day 0 and Day 14	—

Secondary

Measure	Time frame
1. Self-reported Fatigue and Energy Levels Visual Analog Scale (VAS). 2. Immune Markers e.g., IgA and IgG levels (baseline and post study) 3. Incidence of any infections or hospital visits during the study period- for immunity assessment purpose. 4. Safety Evaluation Vital signs, Complete Blood count, HbA1c, RBS, liver and renal function tests (baseline and post study) and adverse event monitoring. 5. Assessment of Change in global assessment for overall change by investigator and participant using 7 point likert scale (Day 7 and day 14)Timepoint: Day 0, Day 7 and Day 14	—

Measure

Time frame

1. Self-reported Fatigue and Energy Levels Visual Analog Scale (VAS). 2. Immune Markers e.g., IgA and IgG levels (baseline and post study) 3. Incidence of any infections or hospital visits during the study period- for immunity assessment purpose. 4. Safety Evaluation Vital signs, Complete Blood count, HbA1c, RBS, liver and renal function tests (baseline and post study) and adverse event monitoring. 5. Assessment of Change in global assessment for overall change by investigator and participant using 7 point likert scale (Day 7 and day 14)Timepoint: Day 0, Day 7 and Day 14

—

Countries

India

Contacts

Public ContactDr Gayathri Sivakumar

Ki3 Private Limited

saheerose@gmail.com9443627722

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026