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CTRI Number  CTRI/2024/10/074643 [Registered on: 03/10/2024] Trial Registered Prospectively
Last Modified On: 03/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of sanjeevani vati to reduce blood sugar level in madhumeha  
Scientific Title of Study   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 ) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vinodkumar N D 
Designation  Kayachikitsa Post Graduate Scholar 
Affiliation  Taranath government ayurvedic medical college and hospital, bellary 583101 
Address  Department of PG studies in Kayachikitsa, Taranath Government Ayurveda Medical College and Hospital, Dr Rajkumar road, Bellary, 583101, Karnataka, India

Bellary
KARNATAKA
583101
India 
Phone  9164753877  
Fax    
Email  ndvinodkumar123@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Fareeda begum shaikh  
Designation  Professor  
Affiliation  Taranath government ayurvedic medical college and hospital, bellary 583101 
Address  Department of PG studies in Kayachikitsa, Taranath Government Ayurveda Medical College and Hospital, Dr Rajkumar road, Bellary, 583101, Karnataka, India

Bellary
KARNATAKA
583101
India 
Phone  9886478611  
Fax    
Email  drfareedabegumshaikh@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vinodkumar N D 
Designation  2nd year pg scholar kayachikitsa 
Affiliation  Taranath government ayurvedic medical college and hospital, bellary 583101 
Address  Taranath Government Ayurveda Medical College and Hospital, Dr Rajkumar road, Bellary, 583101, Karnataka, India

Bellary
KARNATAKA
583101
India 
Phone  9164753877  
Fax    
Email  ndvinodkumar123@gmail.com  
 
Source of Monetary or Material Support  
Department of PG studies in Kayachikitsa, Room number 1, Taranath Government Ayurvedic Medical College and Hospital, Dr Rajkumar road, Bellary, Karnataka 
 
Primary Sponsor  
Name  Pandith Taranath Government Ayurvedic Medical College and Hospital, Bellary, Karnataka-583101 
Address  Department of PG Studies in Kayachikitsa, Room number 1, Taranath Government Aayurvedic Medical College and Hospital, Dr Rajkumar road, Bellary, 583101, Karnataka, India 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vinodkumar ND  Taranath Government Ayurveda Medical College and Hospital, Bellary  Department of PG studies in Kayachikitsa, Taranath Government Ayurvedic Medical College and Hospital, Dr Rajkumar road, Bellary, 583101, Karnataka, India
Bellary
KARNATAKA 
9164753877

ndvinodkumar123@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Taranath Government Ayurvedic Medical College Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-pratimarSaH, प्रतिमर्श (Procedure Reference: charaka samhita siddhi sthana, Procedure details: Gently massage the face & forehead with murchita tila taila. Apply mridu swada over the face. Have the patient lie on their back with a pillow under their neck. Using a dropper or Gokarna, administer 2-4 drops of medicated ghrita into each nostril. Have the patient remain in this position for 1 minute and 15 seconds. Instruct the patient to spit out any medicine that comes into their mouth.)
(1) Medicine Name: Sanjivini vati , Reference: Sharangadhara samhita madyama khanda , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 250(mg), Frequency: bd, Duration: 36 Days
2Comparator Arm (Non Ayurveda)-modern interventionTab Metformin 500mg OD B/FF
3Intervention ArmProcedure-Sadyovirechana (Procedure Reference: Charaka samhita siddhi sthana , Procedure details: Purva karma- ask the patient to take laghu ahara on previous day. Abhyanga & mridu sweda to the patient with murchita Tila taila Pradhana karma- After passing the bowels take 50ml of Nimbamrutadi eranda taila on empty stomach After that patient advised to take warm water sip by sip Pashchat karma- laghu ahara for bhojana )
(1) Medicine Name: Panchanimba ghanvati , Reference: Bhaishajya ratnavali kushtarogadhikara , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Duration: 36 Days
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Subjects presenting with clinical features of hyperglycemia
Subjects with FBS above 126 mg/dl
Subjects with PPBS above 160 mg/dl
Assessment through standard stress scale 
 
ExclusionCriteria 
Details  Patient with type 1 DM
Pregnant and lactating women 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Relief in subjective and objective parameters
 
5 weeks 3 days 
 
Secondary Outcome  
Outcome  TimePoints 
To prevent secondary complications like diabetic nephropathy and neuropathy  5 weeks 3 days 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   14/10/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="1"
Days="8" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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 – 8 

  • 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

 
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