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 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

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•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.

•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

发起方

Indus Biotech Private Limited