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Clinical Trial of Ayurvedic Medicinal Oil KK786 in stress related anxiety

A Prospective, Multi-center, Clinical Study to Evaluate the efficacy and safety of Ayurvedic Medicinal Oil KK786 in mild to moderate stress induced anxiety. - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/06/008796
Enrollment
30
Registered
2017-06-08
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Stress Induced Anxiety

Interventions

Intervention1: KK786 oil: KK786 oil: Glycyrrhiza glabra. Eclipta alba, Rubia cordifolia, Pterocarpus santalinus, Terminalia chebula, Terminalia bellirica, Symplocos racemosa, Amomum subulatum, Nardast

Sponsors

Emami Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Subjects suffering from mild to moderate stress induced anxiety (who achieved scores between 18 and 24 points on the Hamilton Scale for Anxiety) were considered eligible for recruitment in the Study 2.Subjects who gave informed consent and were ready to comply with the study protocol 3.Subjects who were ready to provide regular follow ups till the completion of the study

Exclusion criteria

Exclusion criteria: 1.Subjects suffering from depression, schizophrenia, diabetes mellitus, cardiovascular disease (uncontrolled arrhythmia or acute ischemia) and kidney and liver diseases were not recruited in the Study 2.Subjects who had addiction to drugs, including alcohol were not recruited in the Study 3. Subjects who were using any medication that could interfere with the effect of the oil under study were not recruited in the study 4. Subjects who had participated in any other clinical study in the last 3 months were not included in the study 5. Subjects who were reported pregnant or planning a pregnancy or lactating were not recruited in the study

Design outcomes

Primary

MeasureTime frame
Improvement in Hamilton Rating scale for Anxiety (HAM-A) score with KK786 oil as compared to Baseline score in mild to moderate stress induced anxiety.Timepoint: Day -3, Day 0, Day 14, Day 28

Secondary

MeasureTime frame
1.Changes in QOL with KK786 Oil as compared to Baseline Value 2.Changes in Morning serum cortisol value with KK786 oil as compared to Baseline Value 3.Changes in the level of stress measured on VAS scale as compared to the baseline 4.Changes in the quality of Sleep as compared to the baseline 5.Assessment of effect of KK786 oil on headache, Fatigue, tiredness and Body ache 6.Assessment of effect on Hair Fall 7.Assessment of adverse events Timepoint: Day -3, Day 0, Day 14, Day 28

Countries

India

Contacts

Public ContactDr Sanjay Tamoli

Target Institute of Medical Education and Research

targetinstitute@yahoo.com9322522252

Outcome results

None listed

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