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Trial record 1 of 1 for:   scurvy | Completed
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Study of the Effects of Multiple Medicines on Scorbutic Sailors Upon The High Seas

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
The British Armed Forces
ClinicalTrials.gov Identifier:
NCT00000001
First received: May 1, 1747
Last updated: October 18, 1757
Last verified: May 15, 2014
History of Changes
  Purpose

Evidence regarding optimal methods to cure The Scurvy is currently lacking now, towards the end of the 18th century. The purpose of this study is to evaluate the efficacy of six different approaches to improve the condition of participants with The Scurvy while sailing The High Seas aboard the HMS Salisbury.


Condition Intervention
The Scurvy
Control: Best Supportive Care (BSC) including lenitive electuary, cremor tartar and/or pectoral
Dietary Supplement: Cyder
Dietary Supplement: Elixir of Vitriol
Dietary Supplement: Vinegar
Dietary Supplement: Seawater
Dietary Supplement: Oranges and Lemons
Dietary Supplement: Bigness of Nutmeg with Barley Water

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Brief Inquiry into Seamen Afflicted with The Scurvy Upon The High Seas Where the Consequence of Multiple Medicines Will be Observed in the Treatment of Scorbutic Sailors

Resource links provided by NLM:

MedlinePlus related topics: Scurvy in the Colonial World; Putrid Gums; The Spots; Ham Rigid; Lassitude; Weakness of the Knees; Vitamin C;

Further study details as provided by The Royal British Army, England, United Kingdom:

Primary Outcome Measures:
  • Become fit for duty aboard the HMS Salisbury [ Time Frame: Baseline and 1 fortnight ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in the condition from the beginning of the study [ Time Frame: Baseline and 1 fortnight ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: May 20, 1747
Intended Study Duration: 1 fortnight
Study Completion Date: June 3, 1747
Primary Completion Date: June 3, 1747 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Best Supportive Care Intervention: Best Supportive Care including lenitive electuary, cremor tartar and/or pectoral to help with the symptoms of The Scurvy
Experimental: Cyder 1 quart/day Dietary Supplement: 1 quart of Cyder, daily (with diet of water-gruel sweetened with sugar, fresh mutton-broth, puddings, boiled biscuits with sugar, barley and raisins, rice and currants, sago and wine)
Experimental: Elixir of Vitriol 25 gutts/3 times per day on an empty stomach Dietary Supplement: 25 gutts of Elixir of Vitriol, 3 times daily on an empty stomach (with diet of water-gruel sweetened with sugar, fresh mutton-broth, puddings, boiled biscuits with sugar, barley and raisins, rice and currants, sago and wine)
Experimental: Vinegar 2 spoonfuls/3 times per day on an empty stomach Dietary Supplement: 2 spoonfuls of Vinegar, 3 times daily on an empty stomach (with diet of water-gruel sweetened with sugar, fresh mutton-broth, puddings, boiled biscuits with sugar, barley and raisins, rice and currants, sago and wine)
Experimental: Seawater ½ pint/day Dietary Supplement: ½ pint of Seawater, daily (with diet of water-gruel sweetened with sugar, fresh mutton-broth, puddings, boiled biscuits with sugar, barley and raisins, rice and currants, sago and wine)
Experimental: Oranges & Lemons 2 oranges and 1 lemon/day on an empty stomach Dietary Supplement: 2 Oranges and 1 Lemon, daily on an empty stomach (with diet of water-gruel sweetened with sugar, fresh mutton-broth, puddings, boiled biscuits with sugar, barley and raisins, rice and currants, sago and wine)
Experimental: Bigness of Nutmeg with Barley Water Dietary Supplement: 1 serving of Bigness of Nutmeg and Barley Water, 3 times daily (with diet of water-gruel sweetened with sugar, fresh mutton-broth, puddings, boiled biscuits with sugar, barley and raisins, rice and currants, sago and wine)

Detailed Description:

Participants who enter this study will be placed into one of seven groups. One control group, will receive palliative care measures, while the six experimental arms will receive one of the following treatments: Cyder, Elixir of Vitriol, Vinegar, Seawater, Oranges and Lemons, or Bigness of Nutmeg with Barley Water. These seven arms will be studied for a fortnight to determine which treatments lead to an improvement in scorbutic symptoms and the ability for the seaman to resume duties aboard the HMS Salisbury.

  Eligibility

Ages Eligible for Study:   Of age to be a cabin boy, young enough to still be a salty dog.
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Must be a scorbutic sailor
  2. Must have putrid gums
  3. Must have The Spots
  4. Must exhibit lassitude
  5. Must exhibit weakness of the knees

Exclusion Criteria:

  1. Must not be Nonscorbutic
  2. Must not be afflicted with Complete Edentulism
  3. Must not be a Landlubber
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000001

Locations
HMS Salisbury
The High Seas
Sponsors and Collaborators
British Royal Navy, Captain George Edgcumbe
Investigators
Principal Investigator: Dr. James Lind
  More Information

Publications:
Responsible Party: British Royal Navy Surgeon Dr. James Lind
ClinicalTrials.gov Identifier: NCT00000001     History of Changes
Other Study ID Numbers: BEAT-SCURVY
Study First Received: May 20, 1747
Results First Received: June 3, 1747
Last Updated: 1757
Health Authority: United Kingdom: The British Royal Navy Medical Service

Keywords provided by University of Massachusetts, Worcester:
The Scurvy
Vitamin C deficiency

Additional relevant MeSH terms:
The Scurvy
Ham Rigid
Humid Atmosphere
Lassitude
Chyle
Putrification
Vitamin C

ClinicalTrials.gov processed this record on October 18, 1747

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