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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

May 1, 1747
October 18, 1757
May 20, 1747
June 3, 1747 (final data collection date for primary outcome measure)
Become fit for duty aboard the HMS Salisbury [ Time Frame: 1 fortnight ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00000001 on ClinicalTrials.gov Archive Site
Improvement in the condition from the beginning of the study. [ Time Frame: 1 fortnight ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of the Effects of Multiple Medicines on Scorbutic Sailors Upon The High Seas
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

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • The Scurvy
  • Vitamin D Deficiency
  • Psychosis
  • Schizophrenia
  • Schizoaffective Disorder
  • Control: Best Supportive Care
    Lenitive electuary, cremor tartar and/or pectoral to help with the symptoms of Scurvy
  • Dietary Supplement: Comparator: Cyder
    1 quart of Cyder, daily
  • Dietary Supplement: Comparator: Elixir of Vitriol
    25 gutts of Elixir of Vitriol, 3 times daily on an empty stomach
  • Dietary Supplement: Comparator: Vinegar
    2 spoonfuls of Vinegar, 3 times daily on an empty stomach
  • Dietary Supplement: Comparator: Seawater
    ½ pint of Seawater, daily
  • Dietary Supplement: Comparator: Oranges and Lemons
    2 Oranges and 1 Lemon, daily on an empty stomach
  • Dietary Supplement: Comparator: Bigness of Nutmeg with Barley Water
    1 serving of Bigness of Nutmeg and Barley Water, 3 times daily
  • Control:
    Best Supportive Care
    Intervention: Control: Best Supportive Care including lenitive electuary, cremor tartar and/or pectoral to help with the symptoms of Scurvy
  • Experimental: Group 1
    Cyder in combination with standard diet
    Intervention: Dietary Supplement: Comparator: 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: Group 2
    Elixir of Vitriol in combination with standard diet
    Intervention: Dietary Supplement: Comparator: 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) /div>
  • Experimental: Group 3
    Vinegar in combination with standard diet
    Intervention: Dietary Supplement: Comparator: 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: Group 4
    Seawater in combination with standard diet
    Intervention: Dietary Supplement: Comparator: 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) /div>
  • Experimental: Group 5
    Oranges and Lemons in combination with standard diet
    Intervention: Dietary Supplement: Comparator: 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: Group 6
    Bigness of Nutmeg with Barley Water in combination with standard diet
    Intervention: Dietary Supplement: Comparator: 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) /div>
Lind J. A treatise On The Scurvy: In Three Parts, Containing An Inquiry Into The Nature, Causes, And Cure, Of That Disease: Together With A Critical And Chronological View Of What Has Been Published On The Subject(2nd Edition). 1957. Printed by A Kincaid and A Donaldson.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
June 3, 1747
June 3, 1747 (final data collection date for primary outcome measure)

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
Male
Of age to be a cabin boy, young enough to still be a salty dog.
No
Contact information is only displayed when the study is recruiting subjects
The High Seas
 
NCT00000001
BEAT-SCURVY
No
British Royal Navy Surgeon Dr. James Lind
The British Royal Navy
Not Provided
Principal Investigator: Dr. James Lind British Royal Navy
The British Royal Navy Medical Service
October 18, 1747

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP


Researched Sources:
  1. http://en.wikipedia.org/wiki/James_Lind
  2. http://www.jameslindlibrary.org/lind-j-1753/
  3. http://logica.ugent.be/centrum/preprints/L&LP-Scurvy.pdf#page=7
  4. http://www.jameslindlibrary.org/illustrating/articles/james-lind-aboard-salisbury
  5. https://archive.org/stream/treatiseonscurvy00lind#page/150/mode/2up
R1.1
July 2016