Health Condition 1: G00-G99- Diseases of the nervous system
Conditions
Interventions
Intervention1: INDCA Nasal spray (INDCA-NS): one spray in each nostril twice a day
Control Intervention1: Placebo Nasal spray (PLACEBOCA-NS): one spray in each nostril twice a day
Sponsors
Indus Biotech Private Limited
Eligibility
Inclusion 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 =12 days per year to 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 8. Subjects who can understand and complete the subject oriented English language questionnaires 9. Providing informed written consent.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Headache duration (in hours) documented in the headache diary at baseline, day 7, day 14 and day 28 (values and change from baseline - within the group and between the groups comparisons)Timepoint: baseline, day 7, day 14 and day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| General quality of life of subjects as measured using World Health Organization Quality of Life Questionnaire BREF (WHOQOL-BREF) at baseline, day 14 and day 28 (values within the group and between the groups comparisons)Timepoint: baseline, day 14 and day 28;Headache duration (in days) documented in the headache diary at baseline, day 7, day 14 and day 28 (values and change from baseline - within the group and between the groups comparisons)Frequency of headache attack (number of headache episodes)documented in the headache diary at baseline, day 7, day 14 and day 28 (values within the group and between the groups comparisons)Timepoint: baseline, day 7, day 14 and day 28;Headache pain intensity as measured by the score of visual analogue scale (VAS) at baseline, day 14 and day 28 (values within the group and between the groups comparisons)Timepoint: baseline, day 14 and day 28;ï?¼ The safety in terms of vital signs, Laboratory examination (Haemotology and Serum Biochemistry) of the subjects - between the groups comparisonsTimepoint: baseline, day 7, day 14 and day 28, day 42 for Vital Signs baseline and day 28 for Laboratory Examination;Number of adverse events (AE) or serious adverse events (SAE), either spontaneously reported by the subject, or noticed by the clinician will be recorded during the study - between the groups comparisonsTimepoint: baseline, day 7, day 14 and day 28, day 42;Number of drop-outs -between the groups comparisonTimepoint: baseline, day 7, day 14 and day 28, day 42;Percent compliance â?? Compliance would be recorded based on the amount of study medication (in ml) consumed by the subject since pervious visit - between the groups comparisonsTimepoint: baseline, day 7, day 14 and day 28;Quality of work life as measured using item Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire at baseline, day 14 and day 28 (values within the group and between the groups comparisons)Timepoint: baseline, day 14 and d | — |
Countries
India
Contacts
Public ContactMr Kamal Kammili
Indus Biotech Private Limited
Outcome results
None listed