A CLINICAL STUDY FOR THE EVALUATION OF THE EFFECT OF BALA MOOLA CHURNA IN ASRIGDARA

Menstruation is a physiological function that denotes a healthy reproductive system in a woman. A normal menstrual cycle is vital for every woman's physical and psychological well-being. Asrigdara is a condition where there is excessive or prolonged bleeding. Considering the symptoms, it can be related to Dysfunctional Uterine Bleeding, a state of abnormal bleeding without any clinically detectable organic, systemic or iatrogenic causes. It is common in multiparous women than in nulliparous women. Bala Moola mentioned in Chakradutta is undertaken for the present study to evaluate its efficacy in Asrigdara. A randomized clinical study consisting of two groups, with 20 patients in each group were selected. Group A was given trial drug Bala Moola Churna with milk and honey in the dose of 6 gms twice daily after food for three consecutive cycles. Group B was given Tranexamic acid one tablet twice after food for three-cycle. Both the drugs were given till the bleeding stopped or a maximum of 15 days. The study showed that both the drugs, Bala Moola Churna and Tranexamic acid, were equally effective in reducing the symptoms of Asrigdara at the end of treatment.

Efficacy of Nyagrodh Twak Lepa in Honey bee sting: In-vivo study

Introduction- As Acharya Charaka has explained the local application of Kshirivruksha Twak to cure all types of keeta visha, hence Nyagrodh (Ficus benghalensis L.) Twak Lepa with water as base is selected as Trial drug on Apis Cerana Indica bee sting poisoning. Material and Methods- An in-vivo study on albino mice to know the efficacy of trial drug has been planned after animal ethical clearance. 18 albino mice were prorated into three groups with 6 animals in each group viz. Control group, Trial drug (Nyagrodh Twak Lepa Churna) group and Standard drug (Beclomethasone Dipropionate 0.025% w/w) group. 6 stings were given to each mice and 3 stings were removed after sting operation. All mice were observed for allergic reactions viz. erythema, scaling, fissures, oedema and mortality for a period of 7 days. Histo-pathological changes were also noted after completion of study. Statistical analysis was done using Paired t test. Results- Results revealed that Trial drug had worked more efficiently on Erythema and Oedema while Standard drug worked more efficiently on Scaling and Fissure. Histo-pathology showed that wound healed with Nyagrodh twak lepa and Standard drug have shown almost similar changes while wound in control group showed extensive areas of necrosis. Conclusion- Present study suggests that both Nyagrodh and Beclomethasone can be used in Honey bee sting poisoning but as Nyagrodh being a religious tree can be easily identified by a common man, it can be employed as preliminary treatment for the same before reaching hospital.

An Attempt to Estimate the Noises in Homeopathic Pathogenetic Trials by Employing the Jaccard Similarity Index and Noise Index

Background The critical task of researchers conducting double-blinded, randomized, placebo-controlled homeopathic pathogenetic trials is to segregate the signals from the noises. The noises are signs and symptoms due to factors other than the trial drug; signals are signs and symptoms due to the trial drug. Unfortunately, the existing tools (criteria for a causal association of symptoms only with the tested medicine, qualitative pathogenetic index, quantitative pathogenetic index, pathogenic index) have limitations in analyzing the symptoms of the placebo group as a comparator, resulting in inadequate segregation of the noises. Hence, the Jaccard similarity index and the Noise index are proposed for analyzing the symptoms of the placebo group as a comparator. Methods The Jaccard similarity index is the ratio of the number of common elements among the placebo and intervention groups to the aggregated number of elements in these groups. The Noise index is the ratio of common elements among the placebo and intervention group to the total elements of the intervention group. Homeopathic pathogenetic trials of Plumbum metallicum, Piper methysticum and Hepatitis C nosode were selected for experimenting with the computation of the Jaccard similarity index and the Noise index. Results Jaccard similarity index calculations show that 8% of Plumbum metallicum's elements, 10.7% of Piper methysticum's elements, and 19.3% of Hepatitis C nosode's elements were similar to the placebo group when elements of both the groups (intervention and placebo) were aggregated. Noise index calculations show that 10.7% of Plumbum metallicum's elements, 13.9% of Piper methysticum's elements and 25.7% of Hepatitis C nosode's elements were similar to those of the placebo group. Conclusion The Jaccard similarity index and the Noise index might be considered an additional approach for analyzing the symptoms of the placebo group as a comparator, resulting in better noise segregation in homeopathic pathogenetic trials.

A Clinical Study to Evaluate the Effect of Amrita Guggulu and Guduchi Kwath in the Management of Vatarakta w.s.r. to Gout

In present time, lifestyle disorders are rapidly rising in our society. Over consumption of food, alcohol and fructose sweetened soft drinks in combination with a sedentary lifestyle has resulted in increased prevalence of visceral obesity, metabolic syndrome and gout in all socioeconomic groups of society including the lower socioeconomic status. Gout is one of the major life style disorders. The clinical manifestation and textual references of gout may be attributed with 'Vatarakta', also known as Vatashonita. Vata and Rakta are the Dosha and Dushya respectively which are primarily involved in the pathology of Vatarakta. Virudhaahar and Vihara aggravate Vata dosha and Rakta dhatu. Provocated Vata gets Aavrut with vitiated Rakta dhatu leading to the beginning of pathophysiological cascade of Vatarakta. The patients for this study were diagnosed based on Ayurvedic and modern parameters. Clinical signs and symptoms described in classical texts were considered for the diagnosis of Vatarakta, whereas serum uric acid was considered as investigation based diagnostic tool. Total 15 patients were registered in trial. The selected patients were given the trial drug i.e., Amrita guggulu one gram and Guduchi kwath 50ml twice a day with plain water after food. Out of 15 registered patients, 1 dropout from the trial, 4 patients (28.57%) showed marked improvement, 7 patients i.e., 50% showed moderate improvement and 3 patients 21.43% showed mild improvement. None of patient in present clinical trial remained unimproved or deteriorated during the clinical trials. In the present study, none of the patient reported any adverse effect to the trial drug during study and follow up period.

A CLINICAL STUDY OF SHILAJEET VATI IN PRAMEHA PURVARUPA (PRE-DIABETIC STATE)

Introduction- The incidence of Prameha is increasing rapidly because of changes in dietetic habits and lifestyle. If the Prameha Purvarupa (Pre-diabetic) clinical features are treated by formulation Shilajeet is recommended in Ayurvedic Classics, proven efficacious and widely practised in the management of Prameha (Diabetes). Materi- als and methods- 30 patients from OPD and IPD of Govt. Ayurvedic College & Hospital, Balangir, fulfilling the Subjective and Objective Parameters were registered for the clinical trial. After diagnosis, they were under trial with Ayurvedic formulation Shilajeet Vati treated in a dose of 2 Vati (500mg each) twice daily empty stomach, for a period of 30 days with Ushna Jala. The assessment of subjective and objective parameters was evaluated on the 10th, 20th and 30th day from the day of initiation of trial up to 30 days in order to find the efficacy of the trial by statistical paired ‘t’ test. Observation and results- The average percentage of improvement in subjective parame- ter Prabhuta Mutrata (quantity) 71.43%, Prabhuta Mutrata (frequency) 77.78%, Pipasa (increased thirst) 72.73%, Kshudha (excessive appetite) 72.22%, Kara-pada Daha (burning sensation in hand and feet) 73.81%,Kara-pada Suptata (numbness of hand and feet) 80%, Sweda Pravritti (excessive sweating) 83.33%, Mukha Sho- sha (dry mouth) 79.17%, Mukha Madhurya (sweetness in mouth) 77.78%, Sheeta Priyata (liking for cold things) 80% and Madhura Shukla Mutrata (sweetness in urine) 100% and in objective Parameter fasting plasma glucose 68.89%, postprandial glucose 81.11%, HbA1c 73.33%. It has been observed that the trial drug patients are highly significant (p<0.001) to reduce both Subjective and Objective parameters after 30 days of treatment. Discussion and Conclusion- Prameha is a Kapha Pradhana Tridoshaja Vyadhi in which Meda is a Pradhana Dushya. The drug showed a potent Pramehahar effect which is evident from the reduction in the Subjective Parameter of Prameha and objective parameter of the levels of FBS, PPBS and HbA1c in patients. No side effect was noticed during the clinical study of Shilajeet Vati. Keywords: Prameha, Diabetes, Shilajeet Vati.

Literature Review on Siddha Medicine for the Management of Neerkana Maantham with Utthamani Kudineer- A Drug Review

Siddha medicine is an ancient and traditional system of medicine.. When the three humors (Vatham, Pitham, Kabam) are in proper balance then the person experiences good health; any imbalance of three humors leads to disease. Acute Nasopharyngitis defines an inflammation of the mucous membrane of the naso pharynx. It is characterized by rhinorrhea, nasal obstruction, sneezing, malaise, fever, headache, & myalgia. It may be correlated with Neerkana maantham, one of the 31 types of Maantham in children mentioned in Siddha literature Balavagadam. The symptoms of Neerkana mantham can be managed by Siddha herbal formulation Utthamani kudineer. The main ingredients of the Utthamani kudineer are Chukku, Milagu, Thippili, Omam, Sutta Vasambu, Utthamani leaf, Velai ver, Nochi thulir, Murungai eerku, Nuna eerku. The ingredients of this formulation possess anti-inflammatory, antiviral, anti microbial, antipyretic activities. All the ingredients of trial drug are purely herbals only. It is easily prepared, palatable, assimilates quickly and also safe for pediatric usage in the treatment of Neerkana maantham. Hence, this article gives an insight on the efficacy of Utthamani kudineer for Neerkana maantham (Acute Nasopharyngitis) based on review of various literatures and scientific studies. This review further focuses to improve the research on Siddha herbal medicines.

Evaluation of Comparative Efficacy of Brahmi vs. Haritaki Extract in the Management of Academic Stress in Adolescent Students- A Prakriti based Double-blind Randomized Controlled Trial

Introduction: Prevalence of mental illnesses among adolescents was found 7.3% (N=1191) by NMHS survey 2015-16 whereas the national crime record bureau in 2014 stated 1.8% of students committed suicide due to failure in their exams. The root cause, that is academic stress is often ignored which occurred due to various stressors like physical, mental, family, school, relationship, and social factors of which School factor (56.7%) and academic tests (45.6%) hold maximum association. Proper management can be provided with Ayurveda by Prakriti wise (exploring one physical, physiological and psychological factors) analysis of stress and their coping up strength and effect, when assisted with oral intakes of Ayurveda drugs like Brahmi and Haritaki along with Sattvavajaya Chikitsa having Achar Rasayana, Surya Namaskar, Dharna, and Dhyana practices. Aim and Objectives: The aim is to evaluate the comparative efficacy of Brahmi extract with Sattvavajaya Chikitsa over the effect of Haritaki extract with Sattvavajaya Chikitsa in the management of Academic Stress among adolescent students of different Prakriti. Material and Methods: A double-blind reference standard controlled stratified randomized superiority clinical trial is planned. The sample size of 198 participants with 13% dropout consideration will be enrolled after analysis of their Prakriti and stress level between 5-25 according to the SAAS scale. Total 6 subgroups (3 each for trial drug group and 3 for standard control) will have Vata, Pitta, and Kapha Doshic (V, P & K) dominant Prakriti participants of 10 to 17years of age. Total 33 participants in each subgroup will have the interventions for 90 days. Observation and Results: Participants will be assessed for changes in salivary cortisol, level of academic stress, IQ, and memory before and after the trial. The standard descriptive and inferential statistical measures will be used to assess the effect of interventions. Conclusion: Prakriti analysis will help stressed adolescents to know their strengths and interventions provided will be expected to help a stressed one to minimize stress level and also assist in developing their stress-coping mechanism.

Role and Efficacy of “Katankateriyadi Kwatha” in Patients of Madhumeha (Diabetes Mellitus Type 2): A Clinical Trial

Madhumeha (Diabetes Mellitus) is a by-product of urbanization, proclaimed thousands of years back by Acharya Charaka. India has a high prevalence of diabetes which is increasing in number at an alarming rate. The introduction of oral hypoglycaemic drugs in modern therapeutics materialize to be a breakthrough in the treatment of Diabetes Mellitus initially but subsequently, it was experienced that most of the hypoglycaemic drugs were inadequately effective and were associated with many major side effects. To get rid of this problem, here we aimed to find out an effective and safe remedy to control the disease. This study is an Open-label, standard control, randomized and comparative clinical study with the 3-month assessment of the response of the trial drug “Katankateriyadi Kwatha” on the diabetic patients through subjective and objective parameters. Keywords: Diabetes mellitus, Clinical study, Madhumeha, Katankateriyadi Kwatha.

A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFECT OF VRIKSHAMLA TWAK KASHAYA AND DASHAMOOLA KASHAYA IN UDAVARTHINI YONIVYAPAT

Menstruation is a physiological, natural event in the reproductive stage of the female. Due to a sedentary lifestyle and lack of self-care, stress, untimely food and other factors, many gynaecological problems occur and one of the most common among them is Dysmenorrhea. Painful menstruation is the most common cause which disturbs the mental state of the woman also affecting her day to day activities during the cycle. Pain is the Pratyatma Lak- shana of Vata vikruti mentioned in Ayurveda. Artava Nishkramana is the normal function of Apana vayu which moves in Pratiloma gati and obstructs the pathway of Artava. In our Classics, most of the gynaecological prob- lems are discussed under Yonivyapat. Udavartini Yonivyapat can be co-related and defined as painful menstrua- tion i.e. Dysmenorrhea. Considering the prevalence of dysmenorrhea in the present era, the trial drug Vrikshamlatwak kashaya which possess the properties such as Shoolprashamana and Vatahara was selected to evaluate its effect in the management of Udavartini yonivyapat. Objectives: To compare and evaluate the effect of Vriksham- la Twak kashaya and Dashamoola kashaya in Udavarthini yonivyapat w.r.s primary dysmenorrhea. Methodolo- gy: This research work was a randomized comparative clinical study of 40 patients suffering from symptoms of Udavartini Yonivyapat, who were randomly selected and categorized into 2 groups of 20 patients each. Group A was treated with Vrikshamla Twak kashaya and group B with Dashamoola Kashaya. Both Kashayas were given in Apanakaala (before food) with Sukhoshna Jala as Anupana. Duration of Treatment: 10 days (Starting 7days before the commencement of cycle till 3rd day of the menstrual cycle) for 3 consecutive cycles. Results and In- terpretation- Both the groups showed statistically significant results. Statistically, there was no significant differ- ence between the groups. Conclusion: Both Vrikshamla Twak kashaya and Dashamoola Kashaya had an equal effect in treating Udavartini Yonivyapat. Keywords: Udavartini, Dysmenorrhea, Vrikshamla Twak Kashaya, Dashamoola kashaya.

Use of metformin to prolong gestation in preterm pre-eclampsia: randomised, double blind, placebo controlled trial

Objective To evaluate whether extended release metformin could be used to prolong gestation in women being expectantly managed for preterm pre-eclampsia. Design Randomised, double blind, placebo controlled trial. Setting Referral hospital in Cape Town, South Africa. Participants 180 women with preterm pre-eclampsia between 26+0 to 31+6 weeks’ gestation undergoing expectant management: 90 were randomised to extended release metformin and 90 to placebo. Intervention 3 g of oral extended release metformin or placebo daily, in divided doses, until delivery. Main outcome measure The primary outcome was prolongation of gestation. Results Of 180 participants, one woman delivered before taking any trial drug. The median time from randomisation to delivery was 17.7 days (interquartile range 5.4-29.4 days; n=89) in the metformin arm and 10.1 (3.7-24.1; n=90) days in the placebo arm, a median difference of 7.6 days (geometric mean ratio 1.39, 95% confidence interval 0.99 to 1.95; P=0.057). Among those who continued to take the trial drug at any dose, the median prolongation of gestation in the metformin arm was 17.5 (interquartile range 5.4-28.7; n=76) days compared with 7.9 (3.0-22.2; n=74) days in the placebo arm, a median difference of 9.6 days (geometric mean ratio 1.67, 95% confidence interval 1.16 to 2.42). Among those who took the full dosage, the median prolongation of gestation in the metformin arm was 16.3 (interquartile range 4.8-28.8; n=40) days compared with 4.8 (2.5-15.4; n=61) days in the placebo arm, a median difference of 11.5 days (geometric mean ratio 1.85, 95% confidence interval 1.14 to 2.88). Composite maternal, fetal, and neonatal outcomes and circulating concentrations of soluble fms-like tyrosine kinase-1, placental growth factor, and soluble endoglin did not differ. In the metformin arm, birth weight increased non-significantly and length of stay decreased in the neonatal nursery. No serious adverse events related to trial drugs were observed, although diarrhoea was more common in the metformin arm. Conclusions This trial suggests that extended release metformin can prolong gestation in women with preterm pre-eclampsia, although further trials are needed. It provides proof of concept that treatment of preterm pre-eclampsia is possible. Trial registration Pan African Clinical Trial Registry PACTR201608001752102 https://pactr.samrc.ac.za/ .