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Clinical Trials/CTRI/2018/04/013329
CTRI/2018/04/013329RecruitingPhase 2

A double-blind randomized placebo controlled clinical trial evaluating efficacy of anti-craving homoeopathic medicines in nicotine dependence

ational Institute of Homoeopathy Ministry of AYUSH Govt of India0 sites0 target enrollmentStarted: TBDLast updated:

Trial Snapshot

Phase
Phase 2
Status
Recruiting
Sponsor

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Inclusion Criteria

  • 1. Age 18-65 years
  • 2. Both sexes
  • 3. Participants suffering from Nicotine dependence; i.e. currently using the substance (ICD-10 F17.24) and continuous use (ICD-10 F17.25)
  • 4. Literate patients; ability to read English and/or Bengali
  • 5. Patients willing to participate in the study and giving written informed consent

Exclusion Criteria

  • 1. Patients having mental and behaviour disorder due to psychoactive substance other than tobacco
  • 2. Currently and continuous users of smokeless tobacco
  • 3. Other forms of substance abuse and/or dependence
  • 4. Patient suffering from mental and behaviour disorder due to tobacco, acute intoxication F17.0, Harmful uses F17.1, withdrawal state F17.3, withdrawal state with delirium F17.4, Psychotic disorder F17.5, Amnesic Syndrome F17.6, Residual & late onset psychotic disorder F17.7.
  • 5. Patient suffering from Nicotine dependence who are currently abstinent F17.20, Currently abstinent but in a protracted environment F17.21, Currently on a clinically supervised maintenance or replacement regime [controlled dependence] F17.22, Currently abstinent but receiving treatment with aversive or blocking drugs F17.23, Episodic use F17.26.
  • 6. Self-reported immune-compromised state
  • 7. Patient is already undergoing nicotine replacement therapy
  • 8. Patient already undergoing homoeopathic treatment elsewhere for any chronic disease
  • 9. Any symptoms suggestive of any serious medical conditions that may require active intervention within 6 months

Investigators

Sponsor
ational Institute of Homoeopathy Ministry of AYUSH Govt of India

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