A Clinical Study of Nisha Amalaki Churna in Prameha Purvarupa (Pre-Diabetic State)

Abstract

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 Nisha-amalaki Churna is recommended in Ayurvedic Classics, Proven efficacious and widely practiced in the management of Prameha (Diabetes). Materials and methods- 30 patients from OPD and IPD of Govt. Ayurvedic College & Hospital, Balangir, fulfilling the Subjective and Objective Parameters were registered for clinical trial. After diagnosis they were under trial with Ayurvedic formulation Nisha-amalaki Churna treated in a dose of 3gm twice daily empty stomach, for a period of 30 days with Ushna Jala. The assessment of subjective and objective parameters were evaluated in 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 parameter Prabhuta mutrata (quantity) 90.91%, Prabhuta mutrata (frequency) 83.33%, Pipasa (increased thirst) 71.67%, Kshudha (excessive appetite) 87.04%, Kara-pada Daha (burning sensation in hand and feet) 91.67%, Kara-pada Suptata (numbness of hand and feet) 85.71%, Sweda Pravritti (excessive sweating) 77.78%, Mukha Shosha (dry mouth) 70%, Mukha Madhurya (sweetness in mouth) 80.95%, Sheeta Priyata (liking for cold things) 86.67% and Madhura Shukla Mutrata (sweetness in urine) 100% and in objective Parameter fasting plasma glucose 88.89%, post prandial glucose 96.67%, HbA1c 87.78%. It has been observed that the trial drug patients is highly significant (p<0.001) to reduce both Subjective and Objective parameter 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 potent Pramehahar effect which is evident from the reduction in Subjective Parameter of Prameha and objective parameter of the levels of FBS, PPBS and HbA1c in patients. No side effect was noticed during clinical study of Nisha-amalaki Churna.

Introduction

I. INTRODUCTION

Prameha is a syndrome described in the ancient Ayurvedic texts that includes clinical conditions involved in obesity, prediabetes, diabetes mellitus and metabolic syndrome1. In Ayurveda, Prameha is described as a set of complex clinical disorders characterized with excessive urination (both in frequency and quantity), and turbidity2.

The nature of the turbidity may vary depending upon the body reaction with the doshas3. Now a days the disease Prameha has evolved as a life complicating disorder. Prameha is a Tridoshajanya Vikara due  to the simultaneous vitiation of all the three Doshas4. Ayurveda describes 20 types of Prameha as different clinico-pathological conditions produced out of specific Doshas and Dushyas, showing gross urinary characteristics and clinical manifestations. The fractional changes in Dushyas namely Meda, Mamsa, Kleda, Shukara, Shonita, Vasa, Majja, Lasika, Rasa and Oja, in association with three morbid Doshas manifests different subtypes of Prameha5. Nisha-amalaki Churna is one such drug the use of which has been advocated for Prameha in ancient texts6. So for better and safety treatment Ayurvedic preparation Nisha-amalaki Churna are selected for present research protocol in Prameha.

II. AIM AND OBJECTIVE OF THE STUDY

1. To study the efficacy Nisha-amalaki Churna in the management of Prameha.
2. To find out a suitable herbal drug for the treatment of Prameha.
3. To correlate Prameha in modern parlence.

III. MATERIALS AND METHODS

A. Selection of Patients

The total 30 patients had been selected by a special proforma covering demography along with both Subjective and Objective parameters from OPD and IPD of Govt. Ayurvedic College and Hospital, Balangir and Saradeshweri Govt. Ayurvedic Hospital Balangir. The consent of patients were also taken before clinical trial.

B. Inclusion Criteria

Patients age between 30-65 years of both sexes. Patients having symptoms of Prabhuta Mutrata (frequency of micturition), Pipasa (increased thirst), Kshudha (excessive appetite), Kara-pada Daha (burning sensation in hand and feet), Kara-pada Suptata (numbness of hand and feet), Sweda Pravritti (excessive sweating), Mukha Shosha (dry mouth), Mukha Madhurya (sweetness in mouth), Sheeta Priyata (liking for cold things) Madhura Shukla Mutrata (sweetness in urine). Patients having FBS (100-125mg%), PPBS (140-200mg%) and HbA1c (5.7- 6.4mg/dl) were selected for this study.

C. Exclusion Criteria

Patients age <30 years and >65 years, fasting plasma glucose > 125mg, oral glucose tolerance > 200mg%, HbA1c 6.5% or more, having complications of diabetes like ketoacidosis, nephropathy, neuropathy, retinopathy, and diabetic wounds, chronic, contagious infection disease such as active tuberculosis, hepatits B or C, or HIV, Pregnant and lactating females, active metabolic or gastrointestinal disease that may interfere with nutrient absorption, metabolism, excretion, excluding diabetes, Type-1 diabetes mellitus and Type-2 diabetes mellitus.

D. Criteria for Investigations

Hb%, TLC, DLC, Urine (Routine and Microscopic), Fasting blood sugar (FBS), Post prandial blood sugar (PPBS), HbA1c were investigated initially and follow up periods.

E. Selection of Drug

Nisha-amalaki Churna had been taken for clinical trial. The drug was identified by the experts of Dept. of Dravyaguna and Rasashastra and Bhisajya Kalpana which were approved by DRC and IEC of College and Sambalpur University. Medicines were prepared as per GMP certified method in Mini Pharmacy of College under the supervision of expert of Rasashastra and Bhisajya Kalpana.

F. Method of Preparation of Nisha-amalaki Churna

Good quality and given proportion of Dried raw ingredients (kastha Ausadhis) were taken in specific quantity and powdered separately. The powder was obtained and passed through sieve to obtain fine powder. Both the powder in equal quantity was mixed thoroughly by grinder to obtain homogenous mixture. The fine powder was packed in air tight packets.

G. Administration of Drug

The trial drug Nisha-amalaki Churna was given by oral route in the dose of 3gms/day twice daily empty stomach, for a period of 30 days with Ushna Jala.

H. Assessment Criteria

The Subjective parameters and Objective parameters as per Inclusion Criteria were assessed by the grading score from 0 to 3 according to the severity of disease and favorable shift to back. Both parameter follow-up was taken on 10th, 20th and 30th day of medication. The overall assessments were done considering the percentage relief of both parameters and  statistical evaluation.

IV. OBSERVATION AND RESULT

Within the aforesaid period the demography (Table No.-02) based on Age-Sex-Religion etc. along with incidence of Dashvidha Pariksha (Table No.-03) were observed and assessed.

V. DISCUSSION

The present study was undertaken to interpret the efficacy of Nisha-amalaki Churna in the management of Prameha Purvarupa.

Regarding demographic incidence it has been observed that (Table No.-02) male of middle age group, educated residing in urban areas, middle class, married, mixed diet, addiction of taking tea and having more urination and less sleep were prone to develop Prameha Purvarupa.

Individual Dashavidha- Pariksha was covered and observed that (Table No.-03) the Vata- kapha patients having Madhyama – Sara- Samhanan- Pramana- Satwa- Satmya- Ahara Shakti and Hinabala Vyayama Shakti were manifested with Prameha Purvarupa.

The effect of therapy was assessed on the basis of observations of subjective and objective parameters which was significant (p<0.05) statistically after 30 days. (Table No.-04 and 05)

The outcome of the study showed ample evidence of Nisha-amalaki Churna acting as Pramehahar and showed significant result in reducing the symptoms.  Nisha have Tikta and Katu Rasa, Katu Vipaka, Ushna Virya, and Kaphapittashamka  properties. Amalaki have Pancharasa, Madhura Vipaka, Sheeta Virya and Tridoshashamka properties. This helps in reducing Kapha, Meda and Kleda and due to their Tridosha Shamaka property they can alleviate all the three Doshas in the body. The selected drug showed better improvement on subjective and objective parameter. According to Ayurveda literature both Nisha and Amalaki have many benefits in healthy and diseased state and are mentioned to possess rejuvenating property (Rasayana). This helps in proper body nourishment in each and every Dhatu level. Amalaki is recommended as dietary intervention for treatment of Prameha. Amalaki contains the chromium mineral that regulate carbohydrate metabolism and also act as powerful antioxidant which reverse the oxidative stress and Nisha has Curcuminone which has anti-diabetic effects. Many research works had been carried out on Nisha (Curcuma longa), Amalaki (Emblica officinalis Gaertn), their extracts and chemical ingredients in these two drugs for their effects on Prameha, Madhumeha, Diabetes Mellitus, complications of Diabetes and Antihyperglycemic effects on Blood glucose regulation. Research works show that Nisha-Amalaki Churna best suits for Diabetes management, which affects multisystem, multifunction and multiple organs. Nisha-Amalaki Churna possesses Antihyperglycemic, Antidiabetic, Insulinomimetic, α-Amylase inhibitory and β- glucosidase inhibitory, antioxidant properties. It improves insulin sensitivity and increases glucose uptake by skeletal muscles and is beneficial in the management of Prameha Purvarupa or Pre diabetes. (Table No.-1)

VI. ACKNOWLEDGEMENT

I am very much grateful and thankful to Principal Prof. (Dr.) Arun Kumar Das, Dr. G.B. Acharya, H.O.D Dravyaguna, Dr. S.B. Behera, H.O.D Rasashastra & Bhaisajya Kalpana, Prof. (Dr.) Pradeep Kumar Panda, Dean, Sri Sri College of Ayurveda Science and Research Hospital, Dr. M.R Sahu, Lecturer, RNVV for their grateful blessings. I am also thankful to all my P.G. Scholars friends, Hospital Staff and other Staff of RNVV dept. for their constant helping attitude to complete the research work with a full satisfaction and belief.

Conclusion

In the present study Nisha-amalaki Churna was evaluated for its efficacy in Prameha Purvarupa (Pre-diabetic Condition). The drug showed potent Pramehahar effect which is evident from the reduction in fasting and post prandial blood glucose levels, glycosylated haemoglobin and improvement in subjective parameter including the quality of life, psychological and social well-being. So, the study revealed that Nisha-amalaki Churna can be used as a drug in the management of Prameha Purvarupa. Present study was carried out with certain limitations like fewer samples. Forth coming researchers may pursue further study in a large sample size over a period of longer duration. No side effect was noticed during clinical trial.

References

[1] Pubmed.ncbi.nlm.nih.gov [2] Sushruta Samhita, “Ayurveda Tatwa Sandeepika” by Kaviraja Dr. Ambikadutt Shastri.Vol-1, Edition- Reprint-2014, Chapter-06, Nidanasthana Chaukhamba Bharati Academy. Sloka 6/6 Page No.-326 [3] Astangahrdayam, edited with “Vidyotini” Hindi commentary by Acharya Kaviraja Atrideva Gupta, Edition- Reprint- 2016, Chapter-10, Sloka 10/7 Nidansthana, Chaukhamba Sanskrit pratisthana Page No.-345 [4] Charaka Samhita, “Vidyotinitika” vol-1, by Pandit Kashinatha Panday and Dr. Gorakhnatha Chaturvedi, Edition-Reprint-2016, Chapter-06, Chikitsasthana, Chaukhamba Bharati Academy. Page No.-229 [5] Charaka Samhita, “Vidyotinitika” vol-1, by Pandit Kashinatha Panday and Dr. Gorakhnatha Chaturvedi, Edition-Reprint-2016, Chapter-06, Chikitsasthana, Chaukhamba Bharati Academy. Page No.-229 [6] Astangahrdayam, edited with “Vidyotini” Hindi commentary by Acharya Kaviraja Atrideva Gupta , Edition- Reprint- 2016, Chapter-40, Uttarsthana, Chaukhamba Sanskrit Pratisthana Page No.-832

Copyright

Copyright © 2023 Dr. Esha Dhiman, Dr. Ramnarayan Jitrawal, Dr. Monika. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.