Neurophychariatic implication of Vitamin B 12 and D and validation of safety of Majoon e –Lana in cases of Neurasthenia

PriyankaVerma1✉Email@gmail.com

Regional Research Institute of Unani MedicineIndia

Priyanka Verma, Regional Research Institute of Unani Medicine, India.

biochemistpriyanka @gmail.com

Abstract:-

Neurasthenia which is also called as Zof–e-Asaab in unani terminology is nothing but weakness of nerves, which have symptoms like fatigue, depressed mood, high blood pressure etc. It has been found that Vitamin B12 and D are closely related with each other and are responsible for neurophychariatic implications. There are no specific therapy available for the treatment of neurasthenia. It has been seen that allopathic drugs may cause side effects, thus there is a need to discover safe therapies for neurasthenia .Keeping this in mind a study has been designed to study safety of Majoon – e- lana in cases of Neurasthenia. For validation studies fasting blood sample was taken both at baseline and at end of study while Vitamin B 12 and Vitamin D was measured at baseline to see relationship with Neurasthenia, as they are responsible for neurophychariatic implications. It has been found that both liver and kidney function test were within normal range and nothing abnormal was reported, while values of both Vitamins B 12 and D were on lower side when compared within normal range. As nothing abnormal was reported during validation studies, therefore it can be said that Majoon –e- Lana is safe for human consumption.

Subject: Neurasthenia, Validation Study, Vitamin B12, Vitamin D.

Introduction:-

Neurasthenia is mechanical weakness of nerves which are characterised with symptoms like fatigue, anxiety, headache, palpitations, high blood pressure, neuralgia and depressed mood (1).In recent study it has been found that Vitamin B 12 and D are closely related with each other and are responsible for neurophychariatic implications. Vitamin B12 is also known as cobalamin, is an essential vital nutrient for various bodily functions like production of red blood cells which carry oxygen throughout the body, DNA synthesis and maintaining health and function of nerve cells including that of brain and spinal cord, it is also involved in the production of DNA. It is mainly found in animal products, deficiencies of which can lead to serious health issues.

While on the other hand Vitamin D is a vital nutrient that plays a crucial role in bone health, immune function and overall well-being. It helps the body to absorb calcium, which is essential for strong bones and teeth. Vitamin D may play a role in neurasthenia, as it is involved in brain function and mood regulation. Research suggests that vitamin D deficiency can be associated with neuropsychiatric disorders and may even contribute to the development of conditions like schizophrenia and depression (2, 3and 4)

It was seen that no particular or specific therapy is available for treatment of neurasthenia. It has been found that sedatives like Benzodiazepine are one of the most important therapeutic agents which help in treatment of neurasthenia by improving poor sleep in individuals, having minimum side effects which may cause sedation. While on the other hand tricyclic antidepressants such as imiprammine reduce anxiety, they are not considered as first line of defence as they have side effects. So it is needed to discover safe therapies for neurasthenia.

There are so many Mufrad (single) as well as Murakkab (compound) unani formulations mentioned in classical texts which are Muqawwi-e-Asab (Nervine tonic), Muharrik-e-Asab (Nervine Stimulent) which have been used in the treatment of Ḍu‘f A‘ṣāb by eminent unani Physicians since ages and are known for their efficacy and safety, but they need to be validated on scientific parameters in order to generate data regarding their safety and efficacy. Majoon-e-Lana is one of several unani pharmacopoeial formulations prescribed frequently by unani physicians to treat Ḍu‘f A‘ṣāb i.e. Neurasthenia. It is also used in the treatment of Hemiplegia, facial paralysis, Tremor, Trembling, Arthralgia and Epilepsy. keeping this in mind an open label trial was conducted on cases of Neurasthenia where present clinical study was planned to scientifically validate the safety of pharmacopoeial formulation – Majoon-e-Lana in the treatment of Ḍu‘f A‘ṣāb or Neurasthenia.

Objective:-

It has been seen that Vitamin B 12 and Vitamin D had neuro physcriatic implications on human system while allopathic system of medicine have side effect on human body, keeping that in mind some formulation should be well tested and validated which can be used for the treatment of Neurasthenia. Majoon –e- Lana has been described in the traditional books as a medicine for Neurasthenia but it is not validated. In regard to this a study was designed to validate unani formulation Majoon –e- Lana in cases of Neurasthenia.

The main objective of the study was to explore deficiency of Vitamin B12 and D and validate safety of Majoon –e- Lana in cases of Neurasthenia .For which fasting blood samples were collected at baseline and at completion of the study .Estimation of Vitamin B12 and D was done at the baseline, while for validation liver and kidney function test were performed at baseline and at the end of study.

Material and Methods:

Blood samples were taken from 39 patients of either sex in the age group of 18–60 years of age having Neurasthenia. Patients having Systemic and Chronic debilitating disease, T.B, Diabetes Mellitus etc, Addiction, Pregnancy ,Lactation as well as known case of Carpal tunel syndrome, Peripheral nerve injury, Neuromuscular abnormalities and junction disorders, Myasthenia gravis, Muscular disorders, Diabetic neuropathy ,Autonomic neuropathies, Pregnancy and Lactation were excluded from study.

For validation, of unani pharmacopoeial formulation Majoon –e- Lana, a study was designed, where subjects were first screened for Neurasthenia, followed by dispensing of unani formulation Majoon-e- Lana to screened subjects. Majoon –e- lana was given (5gm twice daily) with plain water after meal. The total duration of treatment was 6 weeks while clinical follow-up was done once in a week while laboratory follow up was done at baseline and at completion of study i.e. 6 weeks. Along with this, study was designed to measure levels of Vitamin D and B12 in cases of Neurasthenia at baseline.

Informed consent was taken from all the participants who participated in this clinical trial

Fasting blood samples were taken for validation study i.e. for Liver and Kidney function test at baseline and at end of study while Vitamin D and B 12 samples were collected only at baseline. Estimation of Urea was done by Uricase UV, Creatinine by Jaffe Kinetic, SGOT and SGPT by IFCC kinetic, Bilirubin by DPD and Alkaline phosphatase by IFCC method both at baseline and on completion of study. While on the other hand estimation of Vitamin B 12 and D was done at baseline by Chemiluminsecence Assay method.

The study has been reviewed and approved by the Institutional ethics Committee of Regional Research Institute of Unani Medicine, New Delhi.

It is to confirm that all the experiments were performed in accordance with relevant guidelines and regulations.

Result and Discussion

Fasting blood samples were collected at the baseline and at the end of the study for the validation study i.e for Liver and kidney function test. Both the Vitamin B 12 and D used to play very important role in maintaining nerve health. Vitamin B 12 is very important for nerve function and myelin synthesis. while Vitamin D have neuroprotective and anti-inflammatory effects, deficiencies in either of them can cause neurological and psychological symptoms.

Estimation of both Vitamin B 12 and D was performed by Chemiluminescense Immuno assay method, having biological reference values between 211.0–911.0 pg/ml and 20–100 ng/ml. It has been found that Vitamin B 12 along with folate is essential for DNA Synthesis and Myelin formation. Vitamin B 12 deficiency can be because of nutritional deficiency, malaabsoption and other gastrointestinal causes. This test is ordered primarily to help diagnose the cause of macrocytic/megloblastic anaemia. While increased levels are seen in Renal Failure, Hepatocellular disorders, myeloproliferative disorders and at times with excess supplementation of vitamin pills.

Estimation of Vitamin D was done by Chemiluminesence Immuno Assay method having biological Reference Level of 20–100 ng/ml. Vitamin D levels less than 20 ng/ml is considered as deficiency, while levels more than 100 ng/ml is considered as toxic, while Vitamin D in the range 20–30 ng/ml is considered as insufficient and ts levels between 30–100 ng/ml is considered sufficient. Cholecalciferol ( Vitamin D 3) is synthesized in the skin from 7-dehydrocholesterol in response to sunlight ,some part also comes from diet and supplements .Ergocalciferol ( Vitamin D 2) comes essentially from diet and supplements. Both Cholecalciferol and Ergocalciferol are converted in liver to 250 H Vitamin D which is considered the best indicator of Vitamin D nutritional Status .Vitamin D toxicity is also recognised, but in rare occurrence.

It has been found that there is significant decrease in SGOT, ALP ( p < 0.05) and non significant decrease in SGPT, Total Bilirubin and Creatinine ( P > 0.05) while on the other hand there is significant increase in Urea ( p < 0.05). It has been found that this increase or decrease in LFT and KFT (Table 1, Fig. 1) fall in the normal range, so it can be said that no side effect has been reported during the study, which proves that this unani formulation is safe for human consumption. To study neurophychariatic implication of Vitamin B12 and Vitamin D in neurasthenia, both Vitamin B 12 and D was measured at the baseline level and it has been found that mean Vitamin B 12 and D came out to be 322.256 pg/ml and 19.146 ng /ml. Normal range of Vitamin B 12 was 211.0- 911.0 pg/ml while on the other hand normal value of Vitamin D was 20–100 ng /ml.

Table 1
Effect of Unani drug Majoon-e- Lana on Liver and Kidney Function Test in cases of Neurasthenia
Parameters Group ↓	SGOT	SGPT	T.Bilirubin	ALP	Urea	Creatinine
Pre- Treatment	31.8462 ± 1.47701	30.0256 ± 1.601	0.7538 ± 0.37	104.5 ± 36.194	22.4564 ± 5.75	0.7079 ± 0.192
Post-Treatment	29.8974 ± 1.10867	26.4359 ± 9.366	0.5715 ± 0.199	98.38 ± 25.93	23.1795 ± 5.36	0.6436 ± 0.168

Fig. 1

Graphical representation showing effect of Unani formulation on liver and kidney function test

The level of Vitamin B 12 and D were on the lower side, which may be the triggering reason for neurasthenia. Therefore it can be said, that improving Vitamin B12 and D levels may help in improving sign and symptoms. Therefore, it can be said that dietary modifications and consumption of Vitamin B 12 and D rich food can help in reduction of neurophychiartic implications. Therefore, it can be said that as Vitamin B12 is essential, so it has to be taken with the diet as the body can’t synthesize or produce it in sufficient amount while in case of Vitamin D which is produced in the body in the presence of sunlight, due to less exposure, it has to be taken with the food.

It was found that there was no abnormality in both the liver and kidney function test, therefore it can be said that it is safe for human consumption.

Data Availability

The Data submitted by the author cannot be shared openly due to Ethical concerns eg to protect study participants privacy .

Funding-

There are no conflict of interest and this study has been funded by CCRUM.

Author Contribution

The experiment performed to validate the safety of Majoon e Lana were performed by Dr Priyanka verma .Data generated after performing test was collected and further analysed by her .Manuscipt was written by her along with the table and figures

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Figure 1:Graphical representation showing effect of Unani formulation on liver and kidney function test

Table 1: Effect of Unani drug Majoon-e- Lana on Liver and Kidney Function Test in cases of Neurasthenia

Parameters Group ↓	SGOT	SGPT	T.Bilirubin	ALP	Urea	Creatinine
Pre- Treatment	31.8462 ± 1.47701	30.0256 ± 1.601	0.7538 ± 0.37	104.5 ± 36.194	22.4564 ± 5.75	0.7079 ± 0.192
Post-Treatment	29.8974 ± 1.10867	26.4359 ± 9.366	0.5715 ± 0.199	98.38 ± 25.93	23.1795 ± 5.36	0.6436 ± 0.168

Yes