Skip to main content
MedPathMedPath Home
Clinical Trials/CTRI/2020/10/028285
CTRI/2020/10/028285
Not yet recruiting
Phase 4

Evaluation of efficacy and safety of intranasal administration of standardized extract of Centella asiatica leaves (INDCA-NS) in the treatment of subjects with tension-type headache: A prospective, randomised, double-blind, placebo-controlled, multicenter, interventional, parallel study.

Indus Biotech Private Limited0 sites0 target enrollmentTBD
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Not specified
Sponsor
Indus Biotech Private Limited
Status
Not yet recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
Indus Biotech Private Limited

Eligibility Criteria

Inclusion Criteria

  • •1\.Male and female subjects aged 18 years and above.
  • •2\.Subjects experiencing episodic tension type headaches which satisfy the following criteria: At least 10 episodes of headache, occurring on \< 1 day per month on average ( \<12 days per year) (Infrequent Tension Type Headache) or occurring 1 to 14 days per month on average for 3 months (\>\=12 days per year to \< 180 days per year) (Frequent Tension Type Headache) and the subject satisfies inclusion criteria 3 through 6\.
  • •3\.Headache lasting from 30 minutes to seven days.
  • •4\.A headache has at least two of the following four characteristics; (i) bilateral location, (ii) pressing or tightening (non\-pulsating) quality, (iii) mild or moderate intensity, (iv) not aggravated by routine physical activity such as walking or climbing stairs.
  • •5\.Both of the following (i) no nausea or vomiting, and (ii) no more than one of photophobia or phonophobia.
  • •6\.Not better accounted for any other ICHD\-3 diagnosis.
  • •7\.Subjects who are experiencing mild to moderate stress; stress score \>\=15 to \<\= 25 as per 21 item Depression, Anxiety, Stress Scale (DASS\-21\) at screening.
  • •8\.Subjects who can understand and complete the subject oriented English language questionnaires
  • •9\.Providing informed written consent.

Exclusion Criteria

  • •1\.Pregnant, planning to become pregnant or breastfeeding women.
  • •2\.Menopausal women experiencing headaches as part of the Menopause Syndrome
  • •3\.Secondary headache to other causes (subarachnoid haemorrhage, cerebral haemorrhage, cerebral embolism, cerebral thrombosis, vascular malformation, arthritis, hypertension, or arteriosclerosis)
  • •4\.Current or past history of a serious illness including, seizures, major psychiatric illness, structural brain disease, liver or kidney failure, organ transplantation, rheumatoid arthritis, uncontrolled hypertension, uncontrolled diabetes or malignancy
  • •5\.Alcohol or substance abuse
  • •6\.Use of anti\-psychotics, serotonergic, antidepressants or benzodiazepines, and other medications that could cause serotonin syndrome for example St Johns Wort and Tramadol in the four weeks prior to commencing the study.
  • •7\.Allergy or sensitivity to any of the ingredients in the study treatment

Outcomes

Primary Outcomes

Not specified

Similar Trials

Active, not recruiting
Not Applicable
Efficacy of intranasal administration of haloperidol compared to intramuscular administration in agitated schizophrenic patients
EUCTR2014-001157-17-ESFundació Parc Taulí40
Not yet recruiting
Phase 4
Efficacy Of Intranasal Tapentadol In Pain Management In Opioid Use DisorderHealth Condition 1: F112- Opioid dependence
CTRI/2021/09/036462GMC RH Patiala
Completed
Phase 2
Comparison of intranasal midazolam and ketamine in peripheral IV access in childrePain and distress associated with peripheral IV access in children in emergency department.
IRCT20200728048242N1Iran University of Medical Sciences100
Active, not recruiting
Not Applicable
Comparative efficacy and safety of two intranasal Triamcinolone Acetonide formulations in persistent allergic rhinitisPersistent allergic rhinitis
EUCTR2005-002742-19-GBeolab Limited24
Completed
Phase 4
To compare the effectiveness and safety of two drugs to cause sedation among children for a diagnostic procedureHealth Condition 1: null- Hearing impairment or speech delay among those children from 1 to 6 years of age who are referred for Auditory Brainstem evoked Response audiometry
CTRI/2014/10/005115Institutional review board82