Comparative clinical trial of Nagarjunabhra ras in Vataj Hridroga

Prof. Dr. S.K. Mishra

We have had enough experience of treating "Vataj Hridrog" since 80's of last century. We initiated this trial as we got some positive results in our clinical practice. That was in a combination but looking to the requirements of scientific enquiry we opted for are ingredients of our formulation for the study. Our objective was to evaluate any ayurvedic formulation for its efficacy in selected cases of Vataj Hridroga.

Materials and methods
Criteria of Selection of cases were
- Features of stable angina (chest pain an emotion/Exertion relieved after rest)
- Chest pain referred to left shoulder or finger and arm without perspiration, to Jaw epigastrium
- Veshthana (Oppression in chest)
- Stambha (Spasmodic Pain in chest)
- Dara (Tachycardia)
- Pramoha (Stuper Syncope)
- Dainya (depression-weakness)
- Shoka (Sorrow-grief)
- Sabda Ashahishnuta (Intolerance for noise)
- Jeerntyarth Vedana (exaggeration of pain after digestion of food) relieved after rest
- History of being treated on IHD lines with relief.
- Enzymology suggestive of myochordial Ischaemila
- Electrocardiogram not suggestive of established myocordial infarction
The patients who has signs of Ischamia in chest leads of ECG were directly diagnosed as Vataj Hridrog, those who did not have were put to stress test. We used MASTER's.

Criteria of assessment
• Detailed Clinical Profile for Kshaya and Vriddhi of Dosa, Dhatu and Mala
• Blood Examination TLC/DLC/ESR
• Urine and Stool examination routine and microscopic.
• Blood sugar estimation fasting-PP
• Serum Cholesterol
• Blood Urea
• Serum Creatinine
• S.G.O.T., LDL and CPK
• X-ray chest AP for size and configuration of heart
• 3 months follow up and weekly progress was recorded.
A cross over customized design was done for each group.

Trial drug
Nagarjunabhra Ras contents 1000 Puti Abhrak Bhasma (Mica) with 7 days trituration (Bhavana) with terminalia arjuna bark decoction

Control drug
• Abana 650mg (Himalaya) two tablets twice daily
• Angised (GTN) 0.5 ml twice or thrice SOS sublingually

Observation and results
The data have been reported as + SD coefficient of correlation between two variables (r) with regression coefficient analysis of variance has been done by chi square (x²) has T-test also has been done for two categorical variables for significance p-value <0.01 has been considered significant

Discussion
In our studies we are in disagreement with the common belief that it is more prevalent in males. We found a clear dominance of the female sex. 40-50 age group was found to be more susceptible for Vataj Hridroga. It required further confirmation.

Vata Vridhi was found to the tune of 58.33 percent and Rasakshaya to the tune of 81.8 percent Rakshkshay to the tune of 45.5 percent. Hence we can safely conclude that Vatavridhi Rasakshaya, Rasvridhi and No Raktavridhi at all may be roughly regarded as an indication for Vataj Hridrog.

Not only this significant Purish Vridhi (67.7 percent) again indicates towards apparent metabolic activities going on in the body by way of accumulation of metabolites which is responsible for Purish Vriddhi. If could be interpreted as an ayurvedic indication to understand the current concept of rise in the value of enzyme like SGOT CPK, LDH and the like.

As stress test in our studies we used masters so to generate more authentic data it would be worth while to use TREADMILL test (TMT) in future studies.

The features encountered in our studies from amongst textual description were Veshthan, Vepathu Hrichhula, Shunyata, Nidralpata, Shwas, Shabd Ashisnuta, Dainya Shoka and Bhaya. By and large we propose that feature must be short listed after a larger study. In our studies these of Nidralpata, Dainya Shabda Asashisnuta Hrichhula and Hridshunyata.

Our studies and interpretation based on our data is in agreement with Chaturvedi G.N. (1973) Upadhyay B.N. (1980), Gupta O.P. (1988), Sharma S.D. (1984) our Ranasingha S.G. (1989) that I.H.D. particularly angina Pectoris should be interpreted as "Vataj Hridrog". However we do not agree with the proposition that the total arena of I.H.D. should be regarded as "Sannipataj Hridrog (Chaudhari K, et. al. 1989)" we have generated sufficient data supported by statistical evaluation for interpretation of angina pectoris as "Vataj Hridroga". Nidralpata (Lack of Sleep) and Shunyata (feeling of void) are two features which are significantly affected by Nagarjunabhra and not affected by control (Abana) puts an additional benefit to Nagarjunabhra use as against Abana.

The number of attacks was not significantly affected by trial drug (p<0.05) whereas the control drug reduced it significantly (p<0.001) this was because of the synergistic action of additional ingredients in Abana the control drug.

The duration of chest pain has been significantly affected by trial drug (p<0.001) as compared to control drug (p<0.01). This is a more utilitarian observation from the patients point of view because it is pain in chest which emotionally disturbs the patients which is not only a matter of immediate concern to the patient but also forms a complex in his mind end perpetuates the process of attacks of angina.
Since we were encouraged in our statistical analysis on the score of pain we further evaluated the severity of chest pain by grading its in both the groups. Here also the trial drug was significantly superior (p<0.001) as against control (p<0.01).

The effect of both trial as well as control drug was highly significant in lowering the blood cholesterol of the patients (p<0.001). There was no significant effect on pulse rate (p<0.01).
However a positive role of the trial drug was observed in lowering the systolic blood pressure (p<0.001) which was superior to control drug (p<0.05) though it is promoted as a treatment for hypertension since the diastolic blood pressure was not significantly by either trial or control drug this needs further evaluate.
We are in full agreement with the published work regarding positive effect of Terminalia arjuna in I.H.D. (Chaturvedi G.N., Dwivedi S. and Udupa K.N.) since arjuna is main ingredient of nagarjunabhra the efficacy of trial drug might have been significantly affected by Abhrak Bhasm in strongly recommended for Hridroga both conventionally and current practice.

Conclusion
1. Vataj Hridroga in corporate angina pectoris
2. The efficacy of Nagarjunabhra Ras is no way inferior to Abana-the control drug which contains 36 ingredients.
3. If can be safely concluded that Nagarjunabhra Ras can easily replace Abana which will avoid unnecessary burden of extra drugs to the patients.
4. It should be further evaluated for its role on lipid profile and preventive role in avoiding precipitation of Heart Attack.

Acknowledgement
The assistance provided by Dr. Sanjay Kumar Sharma in executing the studies and Himalaya Drug Co. and Unjha pharmacies for their supply of drugs in gratefully acknowledged.

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