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The classification of Dravya has been undertaken in many ways, but according to the medicinal value, they are mainly divided into two - Bheshaja and Abheshaja. No study has been documented on Abheshaja to date as per the scholar's knowledge. Therefore, the present study was carried out to understand the concept of Abheshaja by a practical study. The drug Pippali (Piper Longum Linn.) has been contraindicated to be used for a longer duration. A clinical study was carried out on patients with Kaphaja Kasa, to evolve and assess if the drug acts as Abheshaja or not, and if yes, then under what circumstances. The patients of Kaphaja Kasa had been selected by the random sampling method. They were randomly divided into two groups - Group A and Group B. In Group A, test drug Pippali Churna was administered. Group B was a standard control group and Vasa Churna was given to this group. The dose of both the drugs was 4 g B.I.D. The result was assessed after three weeks of drug administration with the help of a specially prepared proforma. All the important hematological, biochemical, urine, and stool investigations were carried out. There was no adverse drug reaction (ADR) observed after the administration of Pippali in this particular study.
The Ayurvedic system of medicine is unique, due to its personalized approach to patient management. The management, that is, the treatment in Ayurveda includes both Shamana and Shodhana procedures. Both these treatment modalities have been covered under the title of Bheshaja, which has been described in detail in all classical texts. Although Ayurveda claims, on the one hand, that every Dravya can be used as medicine, on the other hand, it points toward the concept of Abheshaja by describing Dhatupradushana or Kopana Dravya. The concept of Abheshaja is an untouched field of Ayurveda. The word Abheshaja is available only in Charaka Samhita in Brihattrayi. None of the Laghutrayi texts mention this word. None of the scholars or authors of the modern era have elaborately described this subject in their books. In Caraka Samhita also, Abheshaja has not been explained in detail. Acharya Charaka has defined Abheshaja as things that are opposite in action to those of Bheshaja. Commentator Chakrapani explains that it is responsible for the diseases produced in the body.
All the things of the universe are made by Panchamahabhuta, hence, every substance can be used as medicine with proper Yukti. According to this principle, Abheshaja also is not a separate entity. Similar to how any Dravya works as a Bheshaja, it can work as an Abheshaja too. Some of the Dravyas are Ahitatama or hazardous by nature and some can create untoward effects because of different reasons. There are many factors that require attention before medication and they are Desha, Matra, Kala, Bala, and so on. On account of the ignorance of one of these factors, the drug could not achieve the state that removes the disease, but also can cause extra harmful effects. Therefore, mainly two divisions can be observed in the Ayurvedic classics, which are, Bhesaja and Abheshaja, as far as treatment modality is concerned. The concept of Abheshaja can be compared to the adverse drug reaction (ADR) of modern medicinal science.
Pippali is a drug that has been used most as an ingredient in around 324 formulations described in various available texts. It also has been used as a spice or a food ingredient routinely. However, in Charaka Samhita Vimanasthana, the instruction regarding the use of Pippali is that it should not be consumed in certain conditions. Pippali is described as a drug used to tackle emergencies. However, it should not be taken for a long duration as it causes aggravation of the Doshas.
Depending on the frequency of usage, Pippali is both useful and harmful. When properly used, it produces good results instantaneously, otherwise, it becomes responsible for the accumulation of Doshas. When Pippali is used continuously, it aggravates Kapha, owing to its heaviness, as also the Prakledi (deliquescent) properties; it aggravates Pitta owing to its hot property. It does not alleviate Vata, because it is not adequately unctuous or hot. However, it intensifies the action of the drugs to which it is added. Therefore, Pippali should not be used in excess.
On the other hand, Pippali has been mentioned as Rasayana in Cikitsasthana, where it is indicated to be consumed for a year along with different Anupanas.
The mentioned references prove that the drug Pippali is not Abheshaja by nature, however, it might turn into Abheshaja due to its accessory factors like Kala, Bala, and the like. Hence, this study has been carried out as an attempt to assess the factors or the conditions wherein one drug causes adverse effects. First, the drug was tested on albino rats in an experimental study. When it was observed to be nontoxic or safe, a clinical trial has been undertaken.
To assess the adverse effect of the drug, different investigations have been carried out such as hematological parameters (TLC, DLC, HB%, PCV, ESR, T.RBC count, platelet count), urine analysis (routine and microscopic), stool examinations (macroscopic and microscopic), and biochemical investigations (FBS, S. Cholesterol, LFT, RFT).
The duration of the treatment was for a period of three weeks, that is, 21 days.
The Institutional Research Committee and the Ethical Committee of the Gujarat Ayurved University, Jamnagar, had approved the design of the study. Consent was taken from each patient willing to participate, before the start of trial study.
A total of 39 patients were registered; among them 21 patients in Group A and 12 patients from Group B had completed the treatment.
The maximum number of patients (58.97%) were found in the age group of 40 to 50 years. The maximum number of patients (64.10%) were females. A majority of the patients (69.23%) were taking a Madhura Rasa-dominant diet. About 56.41% were taking a Usna Guna-dominant diet, with the Ruksa Guna dominance in the diet of 41.03%. The maximum number of patients were having Vishamagni, with a percentage of 76.92%. Using Dashavidha Pariksa, the total Atura Bala was assessed. Atura Bala was found to be Madhyama in 56.41% of the patients followed by Pravara Atura Bala in 43.59% of the patients. No patient was observed with having Avara Bala.
A maximum number of patients (56.41%) had given a history of Atishita Annasevana as Aharaja Hetu. A maximum number of patients (48.72%) had expelled sputum after much difficulty. About 66.66% patients had the disease, which was recurrent in nature, either frequently, twice or thrice a year, or once a year. Madhyama Vyadhi Bala was found in 48.72% of the patients, and 43.59% patients had Pravara Vyadhi Bala. With reference to Rtu, a maximum number of patients were registered as Hemanta (38.46%), followed by Sishira (30.77%), and Vasanta Ritu (20.51%).
A maximum number of patients (90.48%) had not developed any kind of adverse events or reactions during the therapy. None of the patients had shown any kind of statistically significant changes in vital parameters like temperature, blood pressure, and the like, or in laboratory investigations like LFT, RFT and so on.
Two of the Pippali-treated group patients had developed Urodaha (chest burning) during the treatment. The symptom obtained during the treatment was mild in nature and not severe. The details of both of the patients have been postulated in Table 1. The results are shown in Figure 1.
According to the Samanya – Vishesa principle, Pippali with the opposite Gunas like Katu Rasa, Laghu, and Tikshna Guna, causes alleviation of Kapha Dosha, with opposite properties like Madhura, Guru, Manda, and so on, of Kapha Dosha. Pippali with Tikshna Guna causes Bhedana of Kapha, which is stuck to the Srotasa by Picchila and Sandra Guna. Once the Dosha is separated from the Srotasa, the Ushna Guna of the drug causes Vilayana of Kapha and generates easy expectoration. Kaphasthivana causes Srotoshuddhi, and hence, Vata Sanga and Vimarga-gamana are corrected. That leads to Vyadhi Shamana.
A maximum number of patients, that is, 90.48% had not developed any kind of adverse events or reactions during the therapy. None of the patients had shown any kind of statistically significant changes in vital parameters like temperature, blood pressure, and so on, or in laboratory investigations like Liver Function Tests, Renal Function Tests, and the like.
Many reasons can be thought of for the drug not causing any harmful effects, although the adverse effects are already mentioned in the classics.
Adverse events observed in two patients in Group A: Two of the Pippali-treated group patients had developed Urodaha (chest burning) during the treatment. The symptom obtained during the treatment was mild in nature and not severe. The details of the patients are given in the clinical observations. By dechallenge and rechallenge, the causality of the reaction due to the drug had turned positive. Both the patients had Pittavata Prakritti. Both the patients were taking Katu Rasa-and Ushna Guna-dominant Ahara. All these factors were significant in evolving dominance over Pitta Dosha in both the patients. Therefore, they might not be able to tolerate the drugs that were Agneya by nature. Although the drug was administered in Kaphaja Kasa in the Vasanta Ritu, that is, Kapha Prakopa Kala, the drug was able to produce only a mild reaction apart from alleviating the Kapha Dosha.
Both the patients had the habit of Adhyashana and Vishamashana, which was suggestive of the chance of some sort of Agnidusti in the patients. On the other hand, both the patients had Vishamagni, which again was suggestive of improper Pachana of the drug.
As all the Dravyas found on the earth are Panachabhautika, Abheshaja is not a separate entity, but there are multiple factors that are responsible for converting Bheshaja into Abheshaja. To prevent the effects from Abheshaja, Yukti is the single most required quality of the physician.
It is very difficult to decide an adverse drug reaction for an Ayurvedic drug, as there are multiple factors like Prakriti, Desha, Kala, Satmya, and so on, which should be considered before drug administration.
In clinical trials, an adverse event* of Pippali that was used for therapeutic purpose, was observed in two out of 21 patients, which is very common according to the classification of adverse drug reactions in modern medicinal science. However, to prove that the drug is Abhesaja or causes an adverse drug reaction, more data is needed from different regions.
(*An adverse event does not mean an adverse drug reaction. In an adverse drug reaction, the causal relationship between the drug and the reaction is been already proven. However, in an adverse event, the causal relationship between the drug and the reaction is still doubtful; in an adverse event, other factors except the drug might be involved).