The
main aim of the study was to assess comparative efficacy of Swarnamakshika bhasma along with Triphala
Ghana on Madhumeha (Diabetes
mellitus). Clinical study has obtained Institutional Ethics Committee clearance
(PGT/7-A/Ethics/2014-2015/1538/2.14) and is registered at Clinical Trial
Registry of India, ICMR, New Delhi, vide CTRI-2015/08/006114. It is a
randomized double blind study. Computer generated Randomization method was used
for generating randomization sequence. Patients of 30 to 60 years of age
fulfilling inclusion criteria were enrolled in the study irrespective of their
sex, religion etc. from OPD and IPD of Rasashastra and Bhaishajya Kalpana of
IPGT & RA, GAU, Jamnagar. Detailed history was taken and physical
examination was done on the basis of a special proforma incorporating signs and
symptoms of the disease. Patients having fasting blood sugar level ≥ 126 mg/dl
or PPBS level ≥200mg/dl were enrolled in study and also assessed to explore the
condition of the patients before and after treatment. Other investigations
carried out were routine hematological (including TLC, DLC, Hb, ESR, Total RBC)
and biochemical investigations (including S. Creatine, SGOT, SGPT, Alkaline
Phosphatase etc.) to exclude any other pathology.
The two trial drugs prepared in the
laboratory were blinded as trial drug - A and B. Hence the selected patients
were randomly placed into two groups:
Group - A : Triphala Ghana with Placebo
Group - B : Swarnamakshika
Bhasma along with Triphala Ghana
Dose :
500 mg twice daily before food
Anupana : Honey
orally
Duration : 56 days (8
weeks)
Follow-up : 28 days (4
weeks)
Table
- : Total number of patients registered in three groups
|
Group
|
No. of patients
|
|
Total Registered
|
Completed
|
Discontinued
|
|
Group-A
|
56
|
51
|
05
|
|
Group-B
|
54
|
50
|
04
|
|
Total
|
110
|
101
|
09
|
Total 110 patients were
registered in the study. 101 patients completed the treatment. Nine patients
discontinued the trial, as three patient of group A and two patients of group B
showed incompatibility to come at regular intervals during treatment course.
Two patients from group A and group B each refused for routine investigations
at regular interval and discontinued treatment.
Majority
of the patients (45.45%) belongs to the age group of 51-60 years, and females (59.09%), while 97.27% patients were married. About 49.09% patients were of Vata Kaphaja Prakruti, 52.73% patients having chronicity of
1-4 years and 57.27% were using some of the allopathic medicines.
All the registered patients presented with Prabhuta
mutrata (Polyuria) 67.27%, 62.73% with Daurbalya (Weakness), 59.09% with Pindikodweshtana (Cramps in calf muscles) and 55.45%
with Kshudhdhikya (Polyphagia)
54.54% with Trishnadhikya (Polydypsia); Kara-Pada-tala Daha (burning sensation in palms & soles) was observed in 46.36% patients,
42.73% with Kara-Pada Suptata
(Numbness in palms & soles), 35.45% which
indicates dominancy of Vata in the
disease. Statistically highly significant (p<0.001) results were obtained in
group B on cardinal symptom like Prabhuta
Mutrata, Kara-Pada-Tala Daha, Kara-Pada Suptata, Gala talu shosha, Shrama,
Pindikodweshtana, and Daurbalya the % change was also more in Group-B. Reduction in symptom Prabhuta mutrata and Daurbalya was significant (p<0.05) in
group A. Rest of all cardinal symptoms were insignificantally decrease in both
of the Groups. However, on comparative assessment drug B showed better
symptomatic relief (statistically insignificant) than test drug A.
Glycemic
control is one of the most important therapeutic challenges in present day
diabetes care. Group A showed statistically insignificant (p>0.05) decrease
in FBS and PPBS. While Group B showed statistically significant (p<0.05)
decrease in FBS and PPBS. In group B 18.79% decrease in urine sugar level was
observed it was statistically significant (p<0.05). While in group A
statistically insignificant decrease of 1.87% in urine sugar was noted
(p>0.05). Results indicate that sugar in urine is well managed by group B. When compared by chi-square test drug B
showed better improvement in FBS, PPBS, Urine sugar parameters while test drug
A produced insignificant effect. Based on these objective parameters, as far as
glycemic control is concerned drug B can be considered marginally better than
test drug A.
Insignificant
decrease in Sr. Cholesterol, Sr. Triglycerides were noted in Group B while
Insignificant decrease in Sr. Cholesterol in Group A. As both the drugs
exhibited anti –hyperlipidemic / lipid lowering effect (on cholesterol,
triglycerrides, LDL and VLDL), hence it can be concluded that, both of the test
drugs could be preferred in obese diabetics and Sthula Pramehi as described by Acharya Charaka.
Overall
effect of therapy:
Analyzing above results it was observed that Group-B
more effective than Group-A in management of Madhumeha (type 2 diabetes mellitus). When compared by chi-square
test drug B was observed better in relief in symptoms thereby improving quality
of life of patients.
Comparison between overall effects of therapy of both the groups
In group A out of 51 completed patients among them
29.41% were unimproved, 37.25%were mildly improved, 29.41% were moderately
improved and 3.92% of patients showed marked improvement at the end of
treatment period. In group B out of 50 completed patients among them 6.00% were
unimproved, 12.00% were mildly improved, 38.00% were moderately improved and
44.00% of patients showed marked response after completion of treatment period. Adverse drug reaction: No undesirable effects were observed
in patients during the clinical trials. There was no undesirable drug
interaction between trial drug and modern oral antidiabetic drug (Biguanides
and Sulphonyurease+ Biguanides).
|