An open labelled RCT study to assess combined effect of sanjivini vati and panchanimba ghana vati with kadaradi kashaya anupana and medhya chatushka ghrita pratimarsha nasya ( transnasal drug delivery ) in stress induced hyperglycemia ( Madhumeha )

NEED FOR THE STUDY

Hyperglycaemia is high glucose concentration in the blood, often associated with diabetes, It is a disorder of abnormal carbohydrate metabolism due to absolute or relative insulin deficiency or resistance1. Diabetes is one of the 9th leading cause for death globally, hence the attention of the people is dragging towards the ayurveda due to their poor life style, metabolic errors. globally 463 million individuals have T2 DM and in India 88 million,  Among those 45.6% are aware of diabetes, 36.1% are on treatment and 5.7% are under control. Nearly 25 million people are at risk of developing diabetes. Hence the prevalence of diabetes in India is 11.3%2.

Madhumeha3 is vatapradhana tridoshaja vyadhi, ama meda kleda dusti expressed in the platform of rakta dusti in the context of vidhishonitiya adhyaya, is most clinical phase to understand treatable hyperglycemia.

Stress4 is emotional or physical tension,in which dopamine, serotonin,epinephrine, glucagon, growth hormone and cortisol play a role in blood sugar levels. When stressed, the body prepares itself by ensuring that enough sugar or energy is readily available. Insulin levels fall, glucagon and epinephrine levels rise and more glucose is released from the liver. At the same time, growth hormone and cortisol levels rise, which causes body tissues (muscle and fat) to be less sensitive to insulin. As a result more glucose is available in the blood stream.

There is a limitation for different OHAs targeting on glucose metabolism and improve the insulin action. But in  case of stress, it is very difficult to manage with only OHA. ayurveda has many procedures to reduce the stress. Rasayana and  Nasya are  the easiest way to practice in daily routine. Trans nasal insulin delivery is new trend . so there is a scope for research.

Sanjeevini Vati5 having Vatsanabha which promotes srava, ballataka, Vacha,triphala  and other drugs which   are having property of hypoglycaemic action,  vacha  is having anti stress action. Pancha nimba ghanavati6 having the action of rasayana, rakta shodhaka, dhatvagni Deepana, Pachana  kledahara effect. Kadaradi Kashaya having mehahara,kledahara effect.

Medhya chatushka Ghrita7 (guduchi,madhuyasti,pandukaparni,shankapushpi) having proven antistress, anti-inflammatory, nootropic, activity. which is administered through nasika. mandookaparni and guduchi have hypoglycemic activity

Hence the research question is whether an oral and trans nasal drug delivery may reduce the stress induced Hyperglycaemia or not so with alternate hypothesis  the study entitled, “AN OPEN LABELLED RCT STUDY TO ASSESS COMBINED EFFECT OF SANJIVINIVATI AND PANCHANIMBA GHANAVATI WITH KADARADI KASHAYA ANUPANA AND MEDHYACHATUSHKA GHRITA PRATIMARSHA NASYA (TRANSNASAL DRUG DELIVERY) IN STRESS INDUCED HYPERGLYCAEMIA (MADHUMEHA) is undertaken

 

HYPOTHESIS:

• H0- Sanjivini vati and panchanimba gana vati with kadaradi kashaya anupana  and medhyachatushka ghrita pratimarshanasya have no effect in stress induced hyperglycaemia (madhumeha)

• H1- Sanjivini vati and panchanimba gana vati with kadaradi kashaya anupana  and medhyachatushka ghrita pratimarshanasya have effect in stress induced hyperglycaemia (madhumeha)

Group: A(N=40) Patients of stress induced hyperglycemia will be randomly allocated in ayurvedic intervention

1.Sanjivini vati

2.Panchanimba ghanavati

Anupana

 

Time of administration

Duration

250 mg capsules  twice  a day

500mg capsules , two caps  twice a day

Kadaradi kashaya 20ml twice day with 40 ml  water

Before  food

36days

|

3.  Pratimarshanasya with

Medhyachatushka ghrita

Duration

2drops  2times a day

 

36 days

|

4. Sadhyovirechana with Payasa eranda taila10

50ml with sukoshna jala

On 9th day and 28th day of the course

(Advised to stop all the oral medication and pratimarshanasya on the day of sadhyovirechana)

    

Group: B (N=40) Patients of Hyperglycemia undergoing modern intervention.

 

DESIGN OF STUDY:

• Study type – Interventional, randomized modern standard controlled

• Estimated enrolment – 80

• Allocation – Randomised

• Intervention model – two arm

• Masking – Open labelled

• Primary purpose – Treatment

• Duration of study- 36 +2=38days

• Follow up – 14 days

ASSESSMENT CRITERIA:

SUBJECTIVE PARAMETERS:

• Dourbalya (Fatigue/ weakness)

• Talukantha shohsam/ pipasa (polydipsia)

• Muhurmuhur mutra pravritti(Polyuria)

• Kara-pada Daha (Burning sensation in Hands & Feet)

OBJECTIVE PARAMETERS-

FBS

PPBS

Hb%

Cohens perceived stress scale