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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 14, 2014
History of Changes
Results First Received: May 1, 1747  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Scurvy
Intervention: Dietary Supplement: Cyder
Dietary Supplement: Elixir of Vitriol
Dietary Supplement: Vinegar
Dietary Supplement: Seawater
Dietary Supplement: Oranges & Lemons
Dietary Supplement: Bigness of Nutmeg with Barley Water

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Trial participants were gathered from a group of scorbutic sailors among the crew of the HMS Salisbury in May, 1747. Participants were recruited and the trial performed on the briny blue.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Control Best Supportive Care, including lenitive electuary, cremor tartar and/or pectoral to help with the symptoms of Scurvy administered as needed for one fortnight.
Cyder One quart of Cyder was administered daily for one fortnight.
Elixir of Vitriol 25 gutts of Elixir of Vitriol were administered three times daily on an empty stomach for one fortnight.
Vinegar Two spoonfuls of vinegar were administered three times daily on an empty stomach for one fortnight.
Seawater One half pint of seawater was administered daily for one fortnight.
Oranges and Lemons Two oranges and one lemon were administered daily for six days (until running out of oranges and lemons).
Bigness of Nutmeg with Barley Water One serving of Bigness of Nutmeg and Barley Water were administered three times daily for one fortnight.

Participant Flow:   Overall Study
    Control     Cyder     Elixer of Vitriol     Vinegar     Seawater     Oranges and Lemons     Bigness of Nutmeg with Barley Water  
STARTED     28     2     2     2     2     2     2  
COMPLETED     28     2     2     2     2     2     2  
NOT COMPLETED     0     0     0     0     0     0     0  



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Any sailor aboard the HMS Salisbury during the 1747 trip to Plymouth, England who had contracted Scurvy was eligible to participate in this trial, the very first controlled clinical trial.

Reporting Groups
  Description
Control Best Supportive Care, including lenitive electuary, cremor tartar and/or pectoral to help with the symptoms of Scurvy administered as needed for one fortnight.
Cyder One quart of Cyder was administered daily for one fortnight.
Elixir of Vitriol 25 gutts of Elixir of Vitriol were administered three times daily on an empty stomach for one fortnight.
Vinegar Two spoonfuls of vinegar were administered three times daily on an empty stomach for one fortnight.
Seawater One half pint of seawater was administered daily for one fortnight.
Oranges and Lemons Two oranges and one lemon were administered daily for six days (until running out of oranges and lemons).
Bigness of Nutmeg with Barley Water One serving of Bigness of Nutmeg and Barley Water were administered three times daily for one fortnight.

Baseline Measures
    Control     Cyder     Elixir of Vitriol     Vinegar     Seawater     Oranges and Lemons     Bigness of Nutmeg with Barley Water  
Number of Participants  
[units: participants]
  28     2     2     2     2     2     2  
Gender  
[units: participants]
             
Female     0     0     0     0     0     0     0  
Male     28     2     2     2     2     2     2  
Region of Enrollment  
[units: participants]
             
The High Seas     28     2     2     2     2     2     2  



  Outcome Measures

1.  Primary:   Become fit for duty upon the HMS Salisbury
Measure Type Primary
Measure Title Become fit for duty aboard the HMS Salisbury
Measure Description Sailor must be feeling well enough that he is fit to resume his duties aboard the HMS Salisbury
Time Frame Baseline and one fortnight
Safety Issue No

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Any sailor aboard the HMS Salisbury during the 1747 trip to Plymouth, England who had contracted Scurvy was eligible to participate in this trial, the very first controlled clinical trial.

Reporting Groups
  Description
Control Best Supportive Care, including lenitive electuary, cremor tartar and/or pectoral to help with the symptoms of Scurvy administered as needed for one fortnight.
Cyder One quart of Cyder was administered daily for one fortnight.
Elixir of Vitriol 25 gutts of Elixir of Vitriol were administered three times daily on an empty stomach for one fortnight.
Vinegar Two spoonfuls of vinegar were administered three times daily on an empty stomach for one fortnight.
Seawater One half pint of seawater was administered daily for one fortnight.
Oranges and Lemons Two oranges and one lemon were administered daily for six days (until running out of oranges and lemons).
Bigness of Nutmeg with Barley Water One serving of Bigness of Nutmeg and Barley Water were administered three times daily for one fortnight.

Measured Values
    Control     Cyder   Elixir of Vitriol  Vinegar   Seawater  Oranges and Lemons Bigness of Nutmeg with Barley Water
Number of Participants Analyzed     28     2     2     2     2     2     2  
Number of sailors who
became fit for duty  
  0     0     0     0     0     1     0  


The consequence was, that the most sudden and visible good effects were perceived from the use of the oranges and lemons; one of those who had taken them, being at the end of six days fit for duty. The spots were not indeed at that time quite off his body, nor his gums sound; but without any other medicine, than a gargarism of elixir vitriol, he became quite healthy before we came into Plymouth, which was on the 16th of June. The other was best recovered of any in his condition; and being now deemed pretty well, was appointed nurse to the rest of the sick.

There is not an instance of a ship’s crew being ever afflicted with this disease, where the before-mentioned fruits [oranges and lemons] were properly, duly, and in sufficient quantity, administered.

2.  Secondary:   Improvement in the condition from the beginning of the study
Measure Type Secondary
Measure Title Improvement in the condition from the beginning of the study
Measure Description Sailor’s condition must have improved to the point of feeling much better even if not yet able bodied
Time Frame Baseline and one fortnight
Safety Issue No

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Any sailor aboard the HMS Salisbury during the 1747 trip to Plymouth, England who had contracted Scurvy was eligible to participate in this trial, the very first controlled clinical trial.

Reporting Groups
  Description
Control Best Supportive Care, including lenitive electuary, cremor tartar and/or pectoral to help with the symptoms of Scurvy administered as needed for one fortnight.
Cyder One quart of Cyder was administered daily for one fortnight.
Elixir of Vitriol 25 gutts of Elixir of Vitriol were administered three times daily on an empty stomach for one fortnight.
Vinegar Two spoonfuls of vinegar were administered three times daily on an empty stomach for one fortnight.
Seawater One half pint of seawater was administered daily for one fortnight.
Oranges and Lemons Two oranges and one lemon were administered daily for six days (until running out of oranges and lemons).
Bigness of Nutmeg with Barley Water One serving of Bigness of Nutmeg and Barley Water were administered three times daily for one fortnight.

Measured Values
    Control     Cyder   Elixir of Vitriol  Vinegar   Seawater  Oranges and Lemons Bigness of Nutmeg with Barley Water
Number of Participants Analyzed     28     2     2     2     2     2     2  
Number of sailors who
became fit for duty  
  0     2     0     1     0     2     0  

Cyder:   Next to the oranges, I thought the cyder had the best effects. It was indeed not very sound, being inclinable to be aigre or pricked. However, those who had taken it, were in a fairer way of recovery than the others at the end of the fortnight, which was the length of time all these different courses were continued, except the oranges. The putrefaction of their gums, but especially their lassitude and weakness, were somewhat abated, and their appetite increased by it.

Elixir of Vitriol:   As to the elixir of vitriol, I observed that the mouths of those who had used it by way of gargarism, were in a much cleaner and better condition than many of the rest, especially those who used the vinegar; but perceived otherwise no good effects from its internal use upon other symptoms.

Seawater, Vinegar, Bigness of Nutmeg and Barley Water:   There was no remarkable alteration upon those who took the electary and tamarind decoction [Bigness of Nutmeg and Barley Water], the seawater, or vinegar, upon comparing their condition, at the end of the fortnight, with others who had taken nothing but a little lenitive electary and cremar tartar, at times, in order to keep their belly open; or a gentle pectoral in the evening, for relief of their breast. Only one of them, while taking the vinegar, fell into a gentle flux at the end of ten days. This I attributed to the genius and course of the disease, rather than the use of the medicine. As I shall have occasion elsewhere to take notice of the effects of other medicines in this disease, I shall hear only observe, that the result of all my experiments was, that oranges and lemons were the most effectual remedies for this distemper at sea. I am apt to think oranges preferable to lemons, though perhaps both given together will be found most favorable.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Publications:

Responsible Party: The British Armed Forces
ClinicalTrials.gov Identifier: NCT00000001     History of Changes
Other Study ID Numbers: BEAT-SCURVY
Study First Received: May 1, 1747
Results First Received: October 18, 1757
Last Updated: May 14, 2014



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