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Clinical evaluation of Ashwagandha on Quality of life in Geriatric Population

Clinical evaluation of efficacy of Ashwagandha on Quality of life in Geriatric Population- Prospective Double-blind placebo controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/11/038315
Enrollment
1080
Registered
2021-11-29
Start date
Unknown
Completion date
Unknown
Last updated
2022-02-21

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

Conditions

None listed

Interventions

None listed

Sponsors

Ministry of AYUSH
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: i. Participants of scheduled Caste community irrespective of gender in the age group 60 to 75 years whose general health is stable with or without medication. ii. Participants willing to provide written informed consent and participate in the study for 3 months

Exclusion criteria

Exclusion criteria: I. Participants with uncontrolled Hypertension with or without medication. (BP>= 160/100 mm of Hg) II. Participants with low blood pressure. (BP III. Participants with uncontrolled Diabetes mellitus with or without medication {HbA1c > 8%). IV. Participants with uncontrolled Hypothyroidism with or without medication (S. TSH >10mIU/ml) V. Participants with concurrent serious cardiac dysfunction or Hepatic Dysfunction (defined as AST and/or ALT > 2 times of the upper normal limit) or Renal Dysfunction (defined as S. creatinine > 1.2 mg/dl), uncontrolled Pulmonary Dysfunction (Asthmatic and COPD patients) or any other concurrent severe disease. VI. Participants taking steroid treatment or any kind of immunosuppressive therapy. VII. Alcoholics and / drug abusers VIII. Participants participating in any other clinical study or having participated in any other study 1 month prior to screening in the present study. IX. Participants who are taking Ayurvedic treatment/medicine for any disease condition for the last 3 months X. Participants with impaired cognition, or with a history or diagnosis of psychiatric illness and neurological disorders etc. XI. Any other condition which PI may think can jeopardize the study.

Design outcomes

Primary

MeasureTime frame
Improvement in Quality of life (QOL) assessed by using SF 36Timepoint: (Time frame: Baseline, 30th day 60th day & 90th day).

Secondary

MeasureTime frame
1. Any improvement in score generated for Ayurveda Swasthya Assessment Scale (SAS) from baseline (Time frame: Baseline and 90th day) 2. Any change in laboratory parameters viz. ESR, hs-CRP and IL-6 (Time frame: Baseline and 90th day) 3. Any change in stress level assessed by using Penns State Worry scale (PSWS) Timepoint: Baseline and 90th day

Countries

India

Contacts

Public ContactDr Sunita Mata

Central Council for Researchin Ayurvedic Sciences

sunita.dr@rediffmail.com8010529320

Outcome results

None listed

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