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The goal of this randomized clinical trial is to evaluate role of date fruit in alleviating morning sickness of pregnancy in pregnant females. The main question[s] it aims to answer [is/are]:
The goal of this randomized clinical trial is to evaluate role of date fruit in
The goal of this randomized clinical trial is to evaluate role of date fruit in alleviating vomiting due to morning sickness of pregnancy and in improving maternal hemoglobin in pregnant females. The main question[s] it aims to answer [are]:
A randomized Controlled trial to assess benefits of date fruit in morning sickness of pregnancy symptoms, inclusive of nausea and vomiting and to improve haemoglobin levels in pregnant females.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Date fruit | Active Comparator | 3 Dates after breakfast |
|
| Antiemetic medication | Active Comparator | Doxylamine succinate 10 mg + Pyridoxine HCl 10 mg |
|
| Appropriate Diet only | Active Comparator | Avoidance of high fat foods and enhanced intake of hydrating fruits and vegetables |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Date fruit | Other | 3 Dates after breakfast |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin | Complete blood picture (Laboratory diagnostic tests) | 12 Weeks |
| Vomiting | PUQE-24 Score Unabbreviated scale title : The Pregnancy-Unique Quantification of Emesis and Nausea (PUQE-24) Minimum Value : 4-6 (Mild) Maximum Value : ≥13 (Severe) Higher Scores mean worst outcome | 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue level | FAS Unabbreviated scale title: Fatigue Assessment Scale (FAS) Minimum Value : Less less than 22 Maximum Value : 35 or more indicates severe fatigue Higher Scores mean worst outcome | 12 weeks |
| Dietary Recall |
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Inclusion Criteria:
Exclusion Criteria:
Females only
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| Name | Affiliation | Role |
|---|---|---|
| Shehla M Baqai, MBBS, FCPS, FICS | Bahria University Health Sciences Campus Karachi | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PNS SHIFA Hospital , Karachi | Karachi | Sindh | Pakistan |
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| ID | Term |
|---|---|
| D014839 | Vomiting |
| D006939 | Hyperemesis Gravidarum |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D048968 | Morning Sickness |
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| ID | Term |
|---|---|
| D002910 | Chronology as Topic |
| C035385 | doxylamine succinate |
| D025101 | Vitamin B 6 |
| D004032 | Diet |
| ID | Term |
|---|---|
| D013995 | Time |
| D055585 | Physical Phenomena |
| D010847 | Picolines |
| D011725 | Pyridines |
| D006573 |
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| Doxylamine succinate 10 mg + Pyridoxine HCl 10 mg | Drug | Doxylamine succinate 10 mg + Pyridoxine HCl 10 mg , One per day |
|
|
| Diet | Other | Avoidance of high in fat foods and enhanced intake of hydrating fruits and vegetables |
|
|
Direct compliance inquired via telephonic communication on regular basis
| 12 weeks |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |