| 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 |
|
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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 |
|
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Details of Secondary Sponsor
|
|
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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 |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Taranath Government Ayurvedic Medical College Institutional Ethical Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | pratimarSaH, पà¥à¤°à¤¤à¤¿à¤®à¤°à¥à¤¶ | (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 | | 2 | Comparator Arm (Non Ayurveda) | | - | modern intervention | Tab Metformin 500mg OD B/FF | | 3 | Intervention Arm | Procedure | - | 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 |
|
|
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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 |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
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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
|
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 Group: A(N=40) Patients of stress induced hyperglycemia will be randomly allocated in ayurvedic intervention | 250 mg capsules twice a day 500mg capsules , two caps twice a day Kadaradi kashaya 20ml twice day with 40 ml water | | | 4. Sadhyovirechana with Payasa eranda taila10 | 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. OBJECTIVE PARAMETERS-
FBS PPBS Hb% Cohens perceived stress scale |