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CTRI Number  CTRI/2022/02/040617 [Registered on: 25/02/2022] Trial Registered Prospectively
Last Modified On: 07/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Clinical Trial To Study The Role Of Sontha Dhaniya Decoction And Boiled Water In Comparison To Normal Water Along With Some Ayurvedic Lifestyle On Weight Among Persons With Prodromal Symptoms Of Prameha (Prediabetes) 
Scientific Title of Study   A Randomised Controlled Clinical Trial To Evaluate The Effect Of Sunthi Dhanyak Sadhita Jala And Ushnodaka As Compared To Normal Water Along With Comprehensive Ayurvedic Lifestyle Intervention On Weight Among Individuals With Prameha Purvaroopa (Prediabetes) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR NEELAM GUPTA 
Designation  PhD Scholar / Assistant Professor 
Affiliation  All India institute of Ayurveda 
Address  Department of Roga Nidana Evum Vikriti Vigyan,PhD Chamber,Academic Block, Third Floor ,All India Institute Of Ayurveda, Gautampuri,Sarita Vihar,Mathura Road,New Delhi

New Delhi
DELHI
110076
India 
Phone  9307391212  
Fax    
Email  neelamsri08@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR ANAND MORE 
Designation  PROFESSOR 
Affiliation  All India institute of Ayurveda 
Address  Department of Roga Nidana Evum Vikriti Vigyan,Academic Block,Room No.305, Third Floor ,All India Institute Of Ayurveda Gautampuri,Sarita vihar,Mathura road,New Delhi

New Delhi
DELHI
110076
India 
Phone  9422025732  
Fax    
Email  drmoreanand@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR SHALINI RAI 
Designation  ASSISTANT PROFESSOR 
Affiliation  All India institute of Ayurveda 
Address  Department Of Roga Nidana Evum Vikriti Vigyan,Academic Block,Room No.307, Third Floor ,All India Institute Of Ayurveda Gautampuri,Sarita Vihar,Mathura Road,New Delhi

New Delhi
DELHI
110076
India 
Phone  9389423843  
Fax    
Email  vd.shalinirai@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Ayurveda, New Delhi 
 
Primary Sponsor  
Name  All India Institute of Ayurveda 
Address  Gautampuri, Sarita Vihar, Mathura Road, New Delhi-110076 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR NEELAM GUPTA  All India Institute of Ayurveda Hospital   Kayachikitsa OPD No.7,Ground Floor, Hospital Block, And Biochemistry/Clinical Pathology Laboratory/Hematology Laboratory Hospital Block, First Floor, AIIA, Sarita Vihar, Mathura Road, New Delhi-110076
New Delhi
DELHI 
9307391212

neelamsri08@gmail.com 
NEELAM GUPTA  A & U Tibbia College & Hospital  OUT PATIENT DEPARTMENT OPD no 15 & 18
Central
DELHI 
9307391212

neelamsri08@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
IEC for PG (Ay)  Approved 
Institutional Ethics committee AIIA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:R739||Hyperglycemia, unspecified. Ayurveda Condition: PRAMEHA-PURVARUPAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Sunthi dhanyaka sadhita jala, Reference: Bhavaprakasha chikitsa 1/27-28, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: sos, Bhaishajya Kal: Muhurmuhu, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: Group A participant will take the medicine as per their thirst 2-2.5 L/day along with some ayurvedic life style intervention i.e. 9 pm to 5 am sleep and 30 minutes morning walk empty stomach.
(2) Medicine Name: Ushnodaka, Reference: Bhavaprakasha chikitsa 1/63-64, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: sos, Bhaishajya Kal: Muhurmuhu, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: Group B participant will take the medicine as per their thirst 2-2.5 L/day along with some ayu
2Comparator ArmDrugClassical(1) Medicine Name: Normal water(100 TDS), Reference: Sushruta sutrasthana 45 chapter, Route: Oral, Dosage Form: Panak/ Sharbat, Dose: 50(ml), Frequency: sos, Bhaishajya Kal: Muhurmuhu, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: -Group C participant will take Normal water (100 TDS) as per their thirst 2-2.5 L/day along with some ayurvedic life style intervention i.e. 9 pm to 5 am sleep and 30 minutes morning walk empty stomach.
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  - Middle class family having RO purifier
- Overweight and obese (BMI 23.0-29.9 kg/m2)
- Any Sign/ symptoms of Prameha Purvaroopa
as per classics along with HbA1C (5.7 to 6.4%)
- Willing to participate and able to comply the study procedures and willing to give written informed consent.
 
 
ExclusionCriteria 
Details  - Pregnancy
- Lactating mothers
- Gestational diabetes
- Diabetic case (patients on oral
hypoglycaemic drugs or insulin)
- Tuberculosis
- Chronic kidney disease
- Chronic Heart diseases
- Chronic liver disease
- Chronic obstructive pulmonary disease
- Malignancies
- Undergone any surgery within 2 months
- Not willing to participate.
- Any other criteria or major illnesses that investigator find inappropriate for the study will not be taken.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in weight of the patients   at baseline and every 15 days of follow up till 3 months of intervention  
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
Changes in HbA1c, Lipid profile, TFT and Changes in quality of life via SF-36 questionnaire  investigations and QOL at baseline and after 3 months on trial completion. 
 
Target Sample Size
Modification(s)  
Total Sample Size="114"
Sample Size from India="114" 
Final Enrollment numbers achieved (Total)= "114"
Final Enrollment numbers achieved (India)="114" 
Phase of Trial
Modification(s)  
Phase 2/ Phase 3 
Date of First Enrollment (India)
Modification(s)  
20/10/2022 
Date of Study Completion (India) 30/09/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 30/09/2023 
Estimated Duration of Trial   Years="1"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Effect of Sunthi dhanyaka sadhita jala and lifestyle modification in the management of prameha purvaroopa(prediabetes):An observation (Journal of Ayurveda care, vol 7,issue 2.April-June 2024, page 79-83) 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

HYPOTHESIS

ALTERNATIVE HYPOTHESIS (H1)

Among individuals with Prameha poorvarupa (prediabetes) from study area who drink Sunthi-Dhanyak sadhita jala/ ushnodaka along with comprehensive ayurvedic lifestyle intervention for at least 3 months results in average reduction of 2.5 to 5 kg of weight as compared to those who drink normal water along with comprehensive ayurvedic lifestyle intervention.

 

 

 

 

NULL HYPOTHESIS (H0)-

None of the three (Sunthi-Dhanyaka sadhita jala /Ushnodaka/Normal water) along with comprehensive ayurvedic lifestyle intervention are effective in Prameha purvaroopa (prediabetes).

INTRODUCTION

Increasing prevalence of type 2 diabetes mellitus (DM) has become alarming, burdening health care systems throughout the world. Pre-diabetes is a condition where a person has impaired glucose metabolism, but hasn’t yet developed diabetes. Prediabetes, also called as intermediate hyperglycaemia. A person with pre-diabetes is at greater risk of going on to develop type 2 diabetes.  Prediabetes is an intermediate step before manifestation of full-blown DM. Effective intervention at this step would help stop/slow progression to DM.

Estimated prevalence of Prediabetes in India 14%. 1 in 6 Indian is suffering from prediabetes (1).

A weight loss of 11% can reverse pre-diabetes in Obese people, a global study shows

(Intervention -8-week Cambridge weight plan formula diet of 800 kcal /day best mix of diet and exercise). There is already good clinical evidence for maintaining a 5% weight loss in non-diabetic people for over 3 years (2). Studies have reported a higher likelihood of progression of prediabetes to type 2 diabetes mellitus (3). Early intervention at Prediabetes stage would help to slow/stop progression towards diabetes.

Human body consists of 80% of water. Now a days everyone is aware of diet but for paan most of us are dependent on mere RO (Reverse osmosis) or DM

(Demineralised) or Kangen (too costly) water and not focusing more than that. In Ayurveda classics Anna is always associated with Paan, adhyaya were named as“Annapaan”in brihat samhitasAnna is important for prana dharan in dhatus whereas paan is important for prana vahan in dhatus (that’s why Ushapaan is indicated as a part of dincharaya starting to cleanse our system). Anna is important for Anuvartana (nutrional status) whereas paan is medium for stabilizing the Samvayata (body framework). We take Anna (diet) less in comparison to paan throughout the day (2-3L). Paan is the medium to distribute adequately poshakansha anna rasa at cellular level via permeability or better absorption or assimilation or opening and smoothening the body Strotas (channels); act as pH and glucose regulators in the body. Water act as a medicine if taken in indigestion, gives strength if taken after digestion of food, good while having meal and bad if taken immediately after meals (4). Decoction of water is doshagna, pachana and laghu (5). Analysing the importance of water and paan, the title for research is chosen.

People who are at risk to develop prediabetes should be screened or detected earlier and needs to be treated via breaking the chain of initial pathogenesis before worsening the condition of developing diabetes type 2. So, it is the approach to treat them in simplest way by Paan and comprehensive Ayurveda intervention.

Taking into account its global prevalence prediabetes control has become the need of hour.


Weight reduction in the prediabetes (with simplest method like Paan along with comprehensive ayurvedic intervention) if could reverse the pathogenesis of Diabetes, which is a silent killer and irreversible condition; burdening health care systems throughout the world.

If it could either delay or slow down its progression by reversing the pathogenesis and stop its conversion into type 2 diabetes then complications associated with this condition like heart disease, stroke, nerve damage, and others could also be avoided. Thus, would be helpful in improving health status of the society.

 
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