DOUBLE-BLIND TRIAL OF DEKOFCYN TO ASSESS ITS USEFULLNESS IN COUGH AND OTHER SYMPTOMS IN CASES OF PULMONARY TUBERCULOSIS
Dr. MADHAV K. KALE, M.D., D.C.D., Hony. Chest Physician, Poona Chest Hospital, Aundh Camp. POONA-411 027.
MEDISCOPE — Vol. XX No. XI, February, 1978 The Journal of Medicine & Surgery T. NAGAR : MADRAS-600 017.
INTRODUCTION :
Pulmonary tuberculosis is a widely prevalent disease in our country. It takes the largest toll of lives. Cough is not only a very early symptom of tuberculosis, but also a troublesome and continuing one during the disease. For some, cough is the main symptom for which they seek advice when tuberculosis is diagnosed. A little cough is inevitable in pulmonary tuberculosis, but when it becomes vexatious and hampers rest and sleep, it should be promptly treated and in no way it should be neglected.
SELECTION OF DEKOFCYN :
Dekofcyn, an Ayurvedic drug was selected for the clinical trial. Each tablet of Dekofcyn contains : Suvarna Vasant Malati 1.5 mg., Talispatra 30 mg., Asan 30 mg., Abhrak Bhasma 15 mg., Praval Bhasma 30 mg., Svarnamakshika Bhasma 15 mg., Ardusi Ghan 15 mg., Amala 30 mg., Galo 30 mg., Pipar 30 mg., Dagdi pashan Bhed 30 mg., Kachura 30 mg., Ardusi 15 mg., Shatavari 30 mg.
Suvarna Vasant Malati : Standard drug for debility following any illness. Used in chronic fevers, tuberculosis, tubercular-adenitis, pleurisy.
Abhrak Bhasma: A standard alterative for chronic wasting diseases, particularly in tuber-culosis. Its effect is enhanced when combined with suitable form of iron. (Svarnamakshikam in Dekofcyn).
Praval Bhasma : Nervine tonic, haemostatic, appetiser, digestive, antiphlegmatic. Used in chest diseases, tuberculosis, haemoptysis and low grade fever.
Svarnamakshikam : An iron-sulphur com-pound well tolerated even by patients with weak digestion. It is alterative, tonic and cooling. Used in anaemia, chest diseases and tuber-culosis.
Talispatra compound : It is an appetiser, car-minative, digestive, expectorant, haemostatic, sedative and antispasmodic.
MATERIALS AND METHODS :
This clinical trial was conducted at the Govt. Poona Chest Hospital, Aundh Camp, Pune, during 1974. 80 consecutive cases of tuber-culosis with troublesome cough were taken up for study. It was Double-blind trial. One set of capsules called X Capsules contained Dekofcyn, each Capsule being equivalent to one commercially available Dekofcyn tablet, and another set called Y Capsule contained placebo and both kinds of Capsules were iden-tical in appearance. The administration of capsules was randomised and it was also done by a different physician. Also the identity of the X and Y Capsules was only verified after the trial period so as to make the trial unbiased, when it was known that X Capsules contained Dekofcyn and Y Capsules contained placebo.
DOSAGE: The trial period was fixed at four weeks. During the first week, X or Y Capsules were given in a dose of 2 capsules, three times a day, and after that, the dose was reduced to 2 capsules, two times a day and was given for three weeks.
Chemotherapy for tuberculosis in the same dosage as they were receiving before the trial was continued in both X and Y Groups during the trial.
INVESTIGATIONS : X-Ray, sputum examination, Vital Capacity, Routine blood examination, Weight, were done in all the cases before treatment and were repeated after treatment.
ESR was done before the trial and was repeated only in 41 cases after the trial. The nature of cough, dry or wet, breathlessness (dyspnoea) and haemoptysis were observed before and after treatment and the results were evaluated as to relief in these symptoms.
AGE GROUPS : There were 56 males and 24 females. The largest age group was of 21-30 Yrs. with 42.5%. The next one was the age Group of 31-40 yrs. with 25% and the third one was the Age Group of 41-50 Yrs. with 16.25%. The Age Groups of 21-40 Yrs. together formed 67.5% of the total. The details are given in Table No. 1.
TABLE I : Showing Age Group and Sex
| X GROUP | Y GROUP | |||||
| Age Group | Males | Females | Males | Females | Total | % |
| 17- 20 years | 3 | 1 | 1 | 1 | 6 | 7.5% |
| 21-30 years | 14 | 6 | 10 | 4 | 34 | 42.5% |
| 31-40 years | 9 | 3 | 5 | 3 | 20 | 25.0% |
| 41-50 years | 7 | 2 | 2 | 2 | 13 | 16.25% |
| 51-60 years | 2 | 1 | 2 | 1 | 6 | 7.5% |
| Over 60 Years | 1 | – | – | – | 1 | 1.25% |
| 36 | 13 | 20 | 11 | 80 | 100.0% | |
COUGH:DRY & WET : 27 patients of the X Group and 15 patients of the Y Group, a total of 42 (52.5%) patients had dry cough. 22 patients of the X Group and 16 patients of the Y Group, a total of 38 patients (47.5%) had wet cough, with expectoration. Expectoration was copious, moderate or mild. Cough, dry or wet, was troublesome variously,
day or night and some times it was changing its pattern. The patient’s rest was disturbed and also he or she generally had sleep. There was no appreciable difference between male or female patients or between different age groups as to the pattern of disturbed cough or its troublesome periods. The details of dry and wet Cough are given in Table No. 2.
TABLE 2. Showing Dry and Wet Cough — X and Y Groups
| Group | X Group
(Dekofcyn) |
Y Group
(Control) |
Total | % |
| Dry Cough
Wet Cough — (With expectoration, copious |
27 | 15 | 42 | 52.5% |
| Total | 49 | 31 | 80 | 100.% |
- T. B. LESIONS : Radiography
Most of the cases of tuberculosis had moderate to advanced disease in lung. Either the patient came late for treatment or the case had deteriorated due to irregular treatment. It is not attempted here to discuss the extent of the damage. However, an analysis is made as to the site of the tubercular lesion. It was found that bilateral T. B. was the most common in this series for the reasons given above (46.2%) next came the lesions on the right side (32.5%) (21.3%). There was no appreciable difference – in these either because of sex or because of difference in age groups. The details are given in Table No. 3.
TABLE 3 : Showing T.B Lesions – X and Y Groups
| T.B | X Group | Y Group | Total | % |
| T.B Rt | 14 | 12 | 26 | 32.5% |
| T.B. Lt | 9 | 8 | 17 | 21.3% |
| T.B Bilateral | 26 | 11 | 37 | 46.2% |
| 49 | 31 | 80 |
100.0% |
HAEMOPTYSIS :
There were only 14 patients (17.5%) with haemoptysis among the total of 80 patients. The details as to X & Y Groups are given in Table No. 4
TABLE 4 – Showing cases of Haemotysis – X and Y Groups
| Groups | Males | Females | Total | % |
| X Group | 5 | 2 | 7 | 50.0% |
| Y Group | 6 | 1 | 7 | 50.0% |
| 11 | 3 | 14 | 100.0% |
Sputum Examination : Positive Cases
29 cases (36.3%) of the total 80 cases were sputum positive. The detail are given in Table No. 5
Showing Sputum Positive and Sputum Negative cases – X and Y Groups
| Sputum -vecases | ||||||
| Group | Males | Females | Total | % | Sputum -vecases | |
| X Group | 11 | 6 | 17 | (34.7%) | 32 (65.3%) | |
RESULTS & DISCUSSION :
Cough : In the Dekofcyn Group (X Group) there was Complete Relief of cough, dry or with expectoration in 28.6% and Satisfactorily Relief, that is occasional cough, but giving rest and undisturbed sleep, in 61.2%. In the Control Group (Y Group) only 16.1% had Complete. Relief and 29.1% had Satisfactory Relief. On the whole, there was Satisfactory Improvement in 89.8% of the Dekofcyn Group, while it was only 45.2% in the Control Group and this difference of 44.6% is noteworthy. The details are shown in Table No. 6, Table No. 7.
TABLE 6. – Showing Results – Dekofcyn Group – Cough (X Group)
| Dekofcyn Group (X Group) | No of cases | Complete Relief | % | Satisfactory Relief(Occ. Cough) | % | Poor Relief | % |
| Dry Cough | 27 | 8 | 29.6% | 17 | 63.0% | 2 | 7.4% |
| Wet Cough (With expectoration) | 22 | 6 | 27.3% | 13 | 59.1% | 3 | 13.6% |
| Total
Total satisfactory improvement |
49 | 14 | 28.6% | 30
44 |
61.2%
89.8% |
5 | 10.2%
|
TABLE 7. – Showing Results – Control Group – Cough (V Group)
| Control Group (Y Group) | No of Cases | Complete Relief | % | Satisfactory Relief (Occ. Cough) | % | Poor Relief | % |
| Dry Cough | 15 | 3 | 20.0% | 5 | 33.3% | 7 | 46.7% |
| Wet Cough –(With Expectoration) |
16 |
2 |
12.5% |
4 |
25.0% |
10 |
62.5% |
| Total
Total satisfactory improvement |
31 | 5 | 16.1% | 9
14 |
29.1%
45.2% |
17 | 54.8% |
Breathlessness : Results :
With Dekofcyn treatment, there was complete Relief in breathlessness in 34.7% and Satisfactory Relief, that is Breathlessness was observed only after prolonged exertion, in 42.9%. While 77.6% showed Satisfactory improvement from breathlessness in the Dekofcyn Group, the Satisfactory improvement in the Control Group was only 64.5%. The details are shown in Table No. 8.
TABLE 8. — Showing Results — Breathlessness — X and Y Groups
| Group | Total cases |
Compelte Relief |
% | Satisfactory Relief |
% | Poor Relief |
%
|
| Dekofcyn — | |||||||
| (X) Group | 49 | 17 | (34.7%) | 21 | (42.9%) | 11 | (22.4%) |
| Control — | |||||||
| (Y) Group | 31 | 7 | (22.6%) | 13 | (41.9%) | 11 | (35.5%) |
HAEMPTYSIS : RESULTS : There were only 14 cases of haemoptysis among the total of 80 cases of tuberculosis. Haemoptysis was on the whole controlled earlier in Dekofcyn Group than in the Control Group. However, as the number of cases of haemoptysis are small, the results are not tabulated for comparison.
Vital Capacity: Results: Vital capacity was done in all the 80 cases before and after the trial. The mean increase of Vital Capacity in the Dekofcyn Group was 260 cc., while the mean increase in the Con-trol Group was only 130 cc. The details are given in Table No. 9 & Table No. 10.
TABLE 9. Showing Results — Vital Capacity — Dekofcyn Group
| Dekofcyn (X) Group | No. of cases |
Mean V.C. before treatment |
Mean V.C. after treatment |
Mean increase in V.C. |
| Males Females | 36 13 |
1430 c.c. 1650 c.c. |
1800 c.c. 1800 c.c. |
370 c.c. 150 c.c. |
| Mean | 1540 c.c. | 1800 c.c | 260 c.c. |
Showing Results — Vital Capacity — Control Group
| Control (X) Group | No. of cases |
Mean V.C. before trial |
Mean V.C. after trial |
Mean increase in V.C. |
| Males Females | 20 11 |
1760 c.c. 1940 c.c. |
1880 c.c. 2080 c.c. |
120 c.c. 140 c.c. |
| Mean | 1850 c.c. | 1980 c.c | 130 c.c. |
CONCLUSION :
1. There was greater relief of cough, dry or with expectoration, with Dekofcyn treatment (89.8%) when compared to the Controlled Group (45.2%).
2. There was appreciable relief in breathless-ness with Dekofcyn treatment when com-pared to the Control Group. Also, Vital Capacity showed increase in the Dekofcyn Group than in Control Group.
3. Difference of sex or age groups did not influ-ence the results of therapy.
4. There was no necessity to discontinue or modify Chemotherapy because of Dekofcyn treatment.
5. No toxic or side effects were observed with Dekofcyn treatment.
SUMMARY:
80 cases of pulmonary tuberculosis having troublesome cough-hampering rest and sleep were treated with Dekofcyn. The clinical trial is Double-blind trial using identically looking cap-sules, one set containing Dekofcyn and another set containing placebo. The trial was conducted during the year 1974 at the Govt. Poona Chest Hospital, Aundh Camp, Poona. This trial has shown that there was greater relief of cough, dry or with expectoration, in the Dekofcyn Group with 89.8% while the result in the Control Group was only 45.2%. Difference of sex or age groups did not influence the results of De-kofcyn therapy. There was no necessity to dis-continue or modify Chemotherapy because of Dekofcyn treatment. No toxic or side effects were observed with Dekofcyn treatment.
ACKNOWLEDGEMENT : Our thanks to the Superintendent, Poona Chest Hospital, Aundh Camp, Poona for per-mission to undertake this trial and publish the results.
We are thankful to Alarsin pharmaceuticals, Bombay-400 023 for their kind co-operation.
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