A Clinical Trial to Evaluate Efficacy of Dhatri Lauh in Management of Annadrava Shoola & Parinama Shoola w.s.r. to Peptic Ulcer

: Annadrava Shoola and Parinama Shoola can be compared to Gastric Ulcer and Duodenal Ulcer as explained in modern medical science respectively. Annadrava Shoola shows the characteristic features of Pain before, during the digestion and after the digestion, while Parinama Shoola shows feature of pain during the digestion of food. Disorders related to the digestive system are more on the rise due to the faulty diet and a example of one such condition is peptic ulcer. Peptic ulcer disease is an ulcer (mucosal erosion) of the Gastro-Intestinal Tract that is usually acidic and thus extremely painful. Peptic ulcer is a worldwide problem and its prevalence in India is quite high. Recent studies suggest approximately 40% of adults at some times of their lives get affected by peptic ulcer. It is

shoola and Parinama shoola both are the diseases of Annavaha Srotas but among the diseases of Annavaha srotas, Annadrava shoola and Parinama shoola predominantly disturb the daily life. The study and use of crude drugs are one of the oldest of medical sciences. Crude drugs have always constituted more than half of the remedical agents in use at any time (FAERGUSON 1958). Various drugs are also described in Ayurvedic texts, for management of Annadrava shoola and Parinama shoola, which are being commonly used by Ayurvedic clinicians, since long time. When considering about the treatment for Annadrava shoola and Parinama shoola, trial drug Dhatri Lauh (herbo-mineral compound) is mentioned in text book of Acharya Chakradatta in the Shoola-Rogadhikar Adhyaya. It is an effective drug in vati form with easy prepration and it is use as a Annadrava shoola and Parinama shoola healing medication in Ayurvedic medicine.

Aims & Objectives:
This clinical trial has the prime objective to know the efficacy of Dhatri

Material and Methods:
This clinical trial was studied in uncomplicated cases of Annadrava shoola and Parinama shoola. Selection of patients were done randomly from O.P.D. and I.P.D. of Roga Nidan and Kaya Chikitsa, Government P.G. Ayurveda College and Hospital, Varanasi, U.P., India. Patients for this clinical study were selected from 17 th Dec 2020 to 10 th May 2021.
The detailed symptomatic case history, demographic profile was recorded according to proforma prepared. After clinical examination, they were subjected to necessary modern laboratory examination, then diagnosis was confirmed and trial drug Dhatri Lauh was given.
In this clinical study total number of 40 patients were taken and all of them were given trial drug Dhatri Lauh 500mg BD with unequal amount of Ghrit and Honey for 30 days. Follow-up was done on each 7 th day of period of study.

Clinical Profile:
The symptoms and sign were graded on a 0,1,2,3 scale for statistical valuation as follows: 0-Absent, 1-mild, 2-moderate, 3-severe Grading of common symptomatology was done in above manners.

Drug :
Trial Drug Dhatri Lauh is very effective and popular herbo-mineral compound mentioned in Ayurvedic text books. It is being used in the case of Annadrava shoola and Parinama shoola since years. In this clinical trial, this Herbo-mineral compound drug is taken to see the efficacy of this drug in the patients of Annadrava shoola and parinama shoola (peptic ulcer). The drug was prepared in Ayurvedic pharmacy, Government P.G. Ayurveda College and Hospital, Varanasi. Its active constituents are: ❖ Amalaki churna (4 part) ❖ Yashtimadhu churna (1part) ❖ Lauha Bhasma (2 part) ❖ Guduchi (as Bhawna Dravya) The dose of drug was given in this clinical study 1000 mg (1 gm) in two divided doses per day with unequal amount of ghrit and honey. The duration was kept 4 weeks.

Assessment Criteria:
Assessment was done by considering the base line of data of Subjective parameters and objective parameters to before and after medication and was compared for assessment of result. All the results were analyzed statistically for p-value using un-paired t-test.

1-On the basis of Etiological factors:
The specific nidanas for Annadrava Shoola and Parinama Shoola. Parinama shoola has not been mentioned in the classical Ayurvedic texts. But the following guidelines can be considered as the causative factors of Annadrava Shoola and Parinama Shoola. antibody-antigen complexes with immobilized H. Pylori antigen on the membrane of the kit. The bound antibody-antigen complexes were subsequently detected by anti-human IgG conjugated to colloidal gold resulting in the appearance of the pink colored bands.

Investigations:
For diagnostic purpose: • USG Abdomen (to exclude other diseases) (if found necessary) Data Collection: patients were thoroughly examined subjectively. Detailed history pertaining to the mode of onset, previous ailment, previous treatment history, family history, habits, routine investigations, USG Abdomen and radiological features are also investigated when needed to exclude other pathologies.

Observation and Results:
Total 40 patients of Annadrava Shoola and Parinama Shoola (Peptic Ulcer) fulfilling the criteria for diagnosis were treated along with validation of disease state.

Overall effect of therapy:
Overall effect of treatment was 83.30 % which is a marked improvement.

DISCUSSION:
At the completion of clinical study, the observational and results have to be interpreted and critically discussed to arrive at logical conclusions. The main aim of this trial is to evaluate the therapeutic effect of Dhatri Lauh in the management of Annadrava Shoola and Parinama Shoola i.e., Peptic Ulcer. By considering the efficacy of Dhatri-Lauh, it was decided to perform a clinical study based on scientific parameters and evaluate the efficacy of the trial drug in management of Annadrava Shoola and Parinama Shoola as it has been already said that clinical description of annadrava shoola and parinama shoola was gradually evolved in texts first of all, by Madhavakar and further scientific input was added by Acharya Vijay Rakshit, Bhava Prakash & Yogaratnakar etc. Hundreds of therapeutic therapies are described in Ayurvedic classics for management of Annadrava Shoola and Parinama Shoola, Dhatri Lauh is among such a formula and contains 4 important ingredients i.e., Amalaki (Emblica officinalis), Yastimadhu (Glycyrrhiza glabra), Lauh Bhasma (Magnetic iron calx) and Guduchi (Tinospora cardifolia) (as Bhavna dravya). Amalaki is a very popular drug and having wide range of actions, but in this regard, its ulcer healing, mucoprotective and enhancing the effect of Lauha are worth to be noted. Yastimadhu (Liquorice) is also an effective ingredient, which has several actions like Anticholinergic, cytoprotective, ulcer healing are important to quote, Lauha Bhasma has quality of Rasayana and also having pacifying effect of Pitta and Kapha. Dhatri Lauh is such a unique compound which possess all such ingredients, by realizing all these unique qualities. Because of these unique ingredients Dhatri lauh was taken for the clinical trial. Regarding the various observations, incidence of Age was most common in middle age group. This can be due to predominance of Pitta Dosha in this age group. Observation of Sex incidence, Peptic ulcer is more common in males than females. Observations regarding dietary habits showed that people who used to take mixed diet, fast foods, spicy diet, tea in empty stomach, Alcohol, Smoking were more prone to develop this disease than those patients who were taking ordinary diet, thus suggesting Pitta prakopaka ahara (aggravating diet) aggravates the disease, indicating that Annadrava Shoola and Parinama Shoola are a pitta dominant disease. Response of treatment was assessed in terms of clinical and investigational improvement. Both, improvement was calculated statistically and by reduction of mean difference of symptoms score. Highly significant improvement (p <0.001) was found in symptoms like Udarshoola (pain in abdomen), Hrillasa (nausea), Chardi (Vomiting), Hritkantha Daha (Burning Sensation in chest and throat), Praseka (Water-Brash), Amlodgar (Acid Regurgitation), Avipaka (Indigestion), Aruchi (Anorexia), Trushna (Excessive Thirst), Arati (Restlessness), Gaurva (Heavyness), Mala Apravruti (Constipation), Swedadhikya (Excessive Perspiration). This trial drug also found Highly significant against H. Pylori infection (p<0.001). It is found that trial drug (Dhatri Lauh) showed excellent response in all of the symptoms of peptic ulcer. Total clinical response was also calculated in each patient and then percentage of reduction was calculated. Investigational (H. Pylori Rapid Test Kit) improvement was also assessed in positive cases of peptic ulcer by repeat examination which is moderated improvement, it may be due to that, it requires long term treatment and further study. ❖ Daha-prashamana property of Amalaki, Yastimadhu might helped in reducing the burning sensation in GIT.

MODERN ASPECT:
❖ Ulcer regression might be because of Anti-ulcer activity of Yastimadhu, Amalaki and Guduchi. ❖ Since, there is a strong causal relation between H. Pylori infection and Peptic ulcer, hence anti H. Pylori activity of Amalaki, Yastimadhu and Guduchi probably stopped the disease progression. ❖ There is an anti-spasmodic property in Amalaki, Lauh bhasma, yastimadhu, which helped in reducing or pulverizing the abdominal pain. ❖ Anti-inflammatory activity of Guduchi, Amalaki, Yastimadhu and lauh bhasma probably helped in checking the process of the disease. ❖ There is a strong relationship between ulcer and stress, so anti stress activity of Guduchi, amalaka might helped in alleviating stress. ❖ Infection with H. Pylori is associated with generation of free radicals which leads to oxidative stress in the gastric mucosa, so anti-oxidative therapy stimulates the healing of peptic ulcer. Anti-oxidative property of Amalaki, Yastimadhu andGuduchi probably helped in checking the progression of the disease, like Licorice has such flavonoids like-Glabrin and Glabridin .

SUMMARY:
During the trial, the available literature in the ancient and modern medical books with regard to Annadrava Shoola and Parinama Shoola along with Peptic ulcer (gastric ulcer and duodenal ulcer) were completed and critically analyzed. This has enabled to understand the physiopathology of the Annadrava Shoola and Parinama Shoola and mode of action of the therapeutics in a better way. The patients suffering from Annadrava shoola and Parinama shoola (peptic ulcer) and fulfill the criteria of selection of the trial were randomly selected. The patients were subjected for detail clinical examination as per the specially designed proforma. Investigations which include Blood typing with Rh, H. Pylori rapid test and L.F.T. were done. H. Pylori rapid test was done before and after the treatment to analyze the effectiveness of clinical trial drug Dhatri lauh on eradication of H. Pylori bacteria. Among the selected 40 patients, obsevations of the trial reveals that the incidence of Annadrava shoola and Parinama Shoola (Peptic Ulcer) is more among the middle age group, in males, middle class, married people, persons having Mandagni, Mixed diet, having addictions like tea/coffee, alcohol, drinking, having irregular and disturbed sleep, having Mental stress, having excessive indulgence in mentioned Aharaja, Viharaja and Mansika Nidana . Response of treatment was assessed in terms of clinical and investigational improvement. Both, improvement was calculated statistically and by reduction of mean difference of symptoms score. Highly significant improvement (p <0.001) was found in symptoms like Udarshoola (pain in abdomen), Hrillasa (nausea), Chardi (Vomiting), Hritkantha Daha (Burning Sensation in chest and throat), Praseka (Water-Brash), Amlodgar (Acid Regurgitation), Avipak (Indigestion) ,Aruchi (Anorexia), Trushna (Excessive Thirst) , Arati (Restlessness), Gaurav (Heavyness), Mala Apravruti (Constipation), Swedadhikya (Excessive Perspiration). This trial drug also found Highly significant against H. Pylori infection (p<0.001). It is found that trial drug (Dhatri Lauh) showed excellent response in all of the symptoms of peptic ulcer.
Total clinical response was also calculated in each patient and then percentage of reduction was calculated.
Investigational (H. Pylori Rapid Test Kit) improvement was also assessed in positive cases of peptic ulcer by repeat examination which is moderated improvement, it may be due to that, it requires long term treatment and further study. After the observations when results were statistically analyzed, the overall effect of therapy reveals that in this clinical study 83.30 % i.e., marked improvement was found.
The study was conducted for a limited period and in a limited number of patients, hence it is suggested that to reveal more about efficacy of the trial drug and its satisfactory therapeutic response, the trial must be taken in a large number of heterogenous population, so that more reliable statistical data can be obtained.