FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/07/070254 [Registered on: 09/07/2024] Trial Registered Prospectively
Last Modified On: 06/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect Of Katankateryadi Kwatha And Shuddha Shilajit In The Management Of Type 2 Diabetes Mellitus 
Scientific Title of Study   A Comparative Clinical Study To Evaluate The Efficacy Of Katankateryadi Kwatha And Shuddha Shilajit In The Management Of Madhumeha W.S.R To Diabetes Mellitus(type 2) 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Neha Kumari 
Designation  Pg Scholar 
Affiliation  Ayurvedic And Unani Tibbia College And Hospital 
Address  Seminar Room Pg Department OF Kayachikitsa Ayurvedic And Unani Tibbia College And Hospital Karol Bagh New Delhi

Central
DELHI
110005
India 
Phone  8826645655  
Fax    
Email  singhneha6452@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sujata Yadav 
Designation  Associate Professor And Head Of Department 
Affiliation  Ayurvedic And Unani Tibbia College And Hospital 
Address  Room No 6 Pg Department Of Kayachikitsa Ayurvedic And Unani Tibbia College And Hospital Karol Bagh New Delhi

Central
DELHI
110005
India 
Phone  9810571653  
Fax    
Email  sujatakcdelhi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sujata Yadav 
Designation  Associate Professor And Head Of Deparment 
Affiliation  Ayurvedic And Unani Tibbia College And Hospital 
Address  Room No 6 Adamji Block Pg Department Of Kayachikitsa Ayurvedic And Unani Tibbia College And Hospital Karol Bagh New Delhi

Central
DELHI
110005
India 
Phone  9810571653  
Fax    
Email  sujatakcdelhi@gmail.com  
 
Source of Monetary or Material Support  
Ayurvedic And Unani Tibbia College And Hospital Karol Bagh New Delhi 110005 India 
 
Primary Sponsor  
Name  Ayurvedic and Unani Tibbia College and Hospital  
Address  Ajmal Khan Road Karol Bagh New Delhi 110005 
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 Neha Kumari  Ayurvedic and Unani Tibbia College and Hospital  Seminar Room Pg Department Of Kayachiktsa Ajmal Khan Road Karol Bagh New Delhi 110005
Central
DELHI 
8826645655

singhneha6452@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC Ayurvedic and Unani Tibbia college and Hospital  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 ArmDrugClassical(1) Medicine Name: katankateryadi katha, Reference: chakardutta prameh chikitsa 35/23, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 12 Weeks, anupAna/sahapAna: No, Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Katankateryadi Kwatha, Reference: Chakardatta Prameha Chikitsa 35/23, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 12 Weeks, anupAna/sahapAna: No, Additional Information: -
(2) Medicine Name: Shuddha Shilajit, Reference: Bhaishajyaratnavali Prameha Chikitsa37/8, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 12 Weeks, anupAna/sahapAna: No, Additional Information: -Shuddha Shilajit in the form of capsule
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Patients of either sex aged between 30 to 65 years.
If yes in any two of the four:
2.Blood sugar –fasting 7.0 – 8.4 mmol/L or ( 125-150mg/dl)
PP – 11.0 – 13.8 mmol/l or( 199-250 mg/dl.)
Glycosylated Hemoglobin (HbA1c) 6.4% - 7.5%
Subjects having classical symptoms of diabetes with random glucose levels ≥200mg/dl (≤250mg/dl)
3.Subjects who are able to come for follow up on fixed visits and are well aware about the treatment plan.(only type 2 DM patients)
4.Subjects willing to participate and able to provide written informed consent. 
 
ExclusionCriteria 
Details  1.Patient suffering from the complications of Diabetes Mellitus like diabetic neuropathy, diabetic retinopathy etc. which require an urgent treatment.
2.patients on any other AYUSH medication for glucose control. Uncontrolled hypertensive subjects(BP with or without medication 140/90 mmHg after 5 min. of rest)
3.patients having any antidiabetic medicine of any other pathy in the last 3 months.
4.patients with any Heart disease or known cases of MI, unstable angina or CHF.
5.patients with current or past diagnosis of malignancy (any malignancy diagnosis in last five years)
6.patients who have a recent history or who are currently known to abuse of alcohol or drugs.
7.patients suffering from major systemic illness necessitating long term drug treatment (rheumatoid arthritis, psycho-neuro-endocrinal disorders,TB, AIDS etc).
8.patients who have completed participation in any other clinical trail during the past six (06 months). 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Primary Outcomes Would Be Measure By Diabetic Specific Biomarker HbA1C Levels  Day1,Day91 
 
Secondary Outcome  
Outcome  TimePoints 
1.To compare the clinical effect of katankateryadi kwatha and shudder shilajit in the management madhumeha.
2.For assessment of safety and effect of drug that can be helpful for the Diabetic community to combat the ailment. 
DAY 1, DAY 91 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 
Date of First Enrollment (India)   26/07/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

INTRODUCTION

Diabetes Mellitus refers to a group of common metabolic disorders that share the phenotype of hyperglycemia .The major etiological factors of the disease are reduced insulin secretion , decreased glucose utilization,and increased glucose production. Polyuria(frequent urination), polydipsia (increased thirst) and polyphagia (increased hunger)are the main characteristic symptoms of this disease. It is one of the initial diseases described in Egyptian manuscripts. In Ancient Ayurvedic texts this disease is described as Madhumeha, a Vataj sub-type of the disease Prameha, characterized by passing of excessive amount of turbid urine.

The incidence of Diabetes has risen dramatically in the recent times presumably because of reduced activity levels and increasing obesity , and the aging of the population which are also the main etiological factors for this disease. According to latest WHO data an estimated 422 million people suffer from DM globally.2 The global prevalence of diabetes among adults has risen from 4.7% in 1980 to 8.5% in 2014.3 The prevalence of this disease increases with the age, however in the recent times it is seen that it has started effecting the younger age groups and even adolescents are suffering from DM. India actually has the highest number of diabetics of any one country in the entire world and is emerging as diabetic capital of the world. According to International Diabetes Federation, there were 69.1 million cases of diabetes in India in 2015.

Hyperglycemia in Diabetes mellitus result either from insulin insufficiency or insulin dysfunction. Type I diabetes (insulin dependent) is caused due to insulin insufficiency because of lack of functional beta cells. Patients suffering from this are therefore totally dependent on exogenous source of insulin while patients suffering from Type II diabetes (insulin independent) are unable to respond to endogenous insulin and can be treated with dietary changes, exercise and medication. Type II diabetes is the more common form of diabetes constituting 90% of the diabetic population.

REVIEW OF LITERATURE:

AYURVEDIC REVIEW:

The disease has been extensively described in ancient Ayurvedic texts of all times including Brihattrayi and Laghuttrayi. Others include Yogratnakar, Vangasen, Chakradatta, Bhaishajya-Ratnavali etcThis disease has been included in Ashtamahagadas by acharya Charaka, Sushruta and Vagbhatta.6 The elaboration of Prameha includes its Nidan, Poorvaroopa, Roopa, Upshaya, Samprapti and Chikitsa. Vitiated tridoshas affects dhatus including Abaddha Meda, Rakta, Shukra, Ambu, Vasa, Lasika, Majja, Rasa, Ojas and Mansa leads to development of the disease and the main site of pathogenesis being the basti or the mootrashya (urinary bladder). Srotas involved are mootravaha and medovaha. The specific symptomatology of twenty types of Prameha’s has been described for diagnostic purpose. The complicated state of the disease in Ayurveda could be read under the heading prameha pidikas.

MODERN REVIEW

Almost all the text books of western (modern) medicine have mentioned Diabetes and its complications. Etiopathogenesis of the disease along with their symptoms, treatment, prognosis and management is described in detail. Evidences are available in Ayuveda and modern medical sciences which justify the correlation of Madhumeha to Diabetes mellitus. Type-1A Diabetes Mellitus results from autoimmune beta cell destruction while individuals with Type-1B Diabetes Mellitus lack immunological markers indicative of an autoimmune destructive process of beta cell. Type 2 DM is a heterogeneous group of disorders characterised by variable degrees of insulin resistance, impaired insulin secretion, and increased glucose production.

TRIAL DRUGS REVIEW:

Indigenous compound formulation used for the trial is KATANKATERYADI KWATHA AND SHUDDHA SHILAJIT.

     1.  KATANKATERYADI KWATHA: This indigenous compound drug formulation is described in Chakradutt for the treatment of Prameha. The contents of the formulations are as follows;

(chakardutta Prameha chikitsa 35/23)

1.DARUHARIDRA

2.MULETHI

3.CHITRAK

4.HARITAKI

5.BIBHITAKI

6.AMALAKI

2.SHUDDHA SHILAJIT:

The description of this drug is available in Bhaishajyaratnavali for the treatment of Prameha. The content of the formulation is only shuddha shilajit. (Bhaishajyaratnavali Prameha Chikitsa 37/8)

Shilajit (Latin- Asphaltum punjabianum) is one of the MAHARAS (classified drug) mentioned in the classical texts (Rasgranthas).

It has many synonyms in the texts which suggest that it is obtained from the mountain tops, and is an exudate which is found in the summer season. 

Sanskrit name- Shilajatu         

Latin name- Asphaltum punjabianum       

Synonyms – Shaileya, Shila niryas, Ashmaj, Girij, Adrij, Ashmaj, Ashmotth, Ashmlaksha, Girijatu      

DIAGNOSTIC CRITERIA: Diagnosis will be made on the basis of symptoms given in ancient texts and modern literature. Laboratory investigations and clinical findings shall be considered for making diagnosis. WHO criteria for diagnosis of diabetics condition are as follows:

·      Fasting plasma glucose  7.0 – 8.4 mmol/L or ( 125-150mg/dl)   or

·      Two hour plasma glucose 11-13.8 mmol/L (199- 250mg/dl) during an oral glucose tolerance test.  

·      Note: 1. Random is defined as without regard to time since the last meal. Fasting is defined as no caloric intake for at least 8 hrs.

·      The test should be performed using a glucose load containing the equivalent of 75g anhydrous glucose dissolved in water.

 

      INVESTIGATIONS:

      Routine Investigations:

      Routine investigation will be done before treatment and after treatment 

         CBC

         LFT

         KFT

         Lipid profile

         Urine-routine and microscopic examination 

     Specific investigations:

·    FBS & PP will be done every month.

·    HbA1c (Glycosylated Hemoglobin)  (Before and after treatment)

·      RBS (at every 15th day)


 
Close