| 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 |
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Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
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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
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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 |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
|
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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 |
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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 |
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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 |
|
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Source of Monetary or Material Support
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| All India Institute of Ayurveda, New Delhi |
|
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Primary Sponsor
|
| Name |
All India Institute of Ayurveda |
| Address |
Gautampuri, Sarita Vihar, Mathura Road, New Delhi-110076 |
| 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
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 |
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Details of Ethics Committee
Modification(s)
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| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| IEC for PG (Ay) |
Approved |
| Institutional Ethics committee AIIA |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:R739||Hyperglycemia, unspecified. Ayurveda Condition: PRAMEHA-PURVARUPAM, |
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Intervention / Comparator Agent
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| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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 | | 2 | Comparator Arm | Drug | Classical | | (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. |
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Inclusion Criteria
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| 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.
|
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| 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.
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Open Label |
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Primary Outcome
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| Outcome |
TimePoints |
| Change in weight of the patients |
at baseline and every 15 days of follow up till 3 months of intervention |
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Secondary Outcome
Modification(s)
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| 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. |
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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) |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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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“Annapaanâ€in brihat samhitas. Anna 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. |