| CTRI Number |
CTRI/2025/03/083382 [Registered on: 25/03/2025] Trial Registered Prospectively |
| Last Modified On: |
18/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study On Effectiveness of Chitrakadi Churna and Lifestyle changes in improving Prediabetes with Special references to HbA1C. |
|
Scientific Title of Study
|
A Randomized Clinical Study To Evaluate Efficacy Of Chitrakadi Churna & Lifestyle Management In Prediabetes With Special References To HbA1C. |
| 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 HETALBEN M PATEL |
| Designation |
PG scholar |
| Affiliation |
PG STUDANT AT THIS COLLEGE |
| Address |
D Y Patil Deemed to be university school of Ayurveda, First Floor OPD No 1, Department of Kayachikitsa, Sector 7, Nerul , Navi Mumbai, MAHARASTRA, 400706.
Thane
MAHARASHTRA
400706
India |
| Phone |
8805816096 |
| Fax |
|
| Email |
hetalpatel1398@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neena Damle |
| Designation |
assistant professor |
| Affiliation |
Padmashree Dr D Y Patil school of Ayurveda,Nerul,thane,Navi Mumbai. |
| Address |
D Y Patil Deemed to be university school of Ayurveda, First Floor OPD No 1, Department of Kayachikitsa, Sector 7, Nerul , Navi Mumbai, MAHARASTRA, 400706.
D Y Patil School of Ayurveda,3rd floor , Dept of kayachikitsa, D Y patil Vidhya agar, sector 7, Nerul, Navi Mumbai.
Thane
MAHARASTRA
400706
Thane
MAHARASHTRA
400706
India |
| Phone |
7977153510 |
| Fax |
|
| Email |
neena.damle@dypatil.edu |
|
Details of Contact Person
Public Query
|
| Name |
DR HETALBEN M PATEL |
| Designation |
PG scholar |
| Affiliation |
Padmashree Dr D Y Patil school of Ayurveda,Nerul,thane,Navi Mumbai. |
| Address |
D Y Patil Deemed to be university school of Ayurveda, First Floor OPD No 1, Department of Kayachikitsa, Sector 7, Nerul , Navi Mumbai, MAHARASTRA, 400706.
D Y Patil Deemed to be university school of Ayurveda, First Floor OPD No 1, Department of Kayachikitsa, Sector 7, Nerul , Navi Mumbai, MAHARASTRA, 400706.
Thane
MAHARASHTRA
400706
India |
| Phone |
8805816096 |
| Fax |
|
| Email |
hetalpatel1398@gmail.com |
|
|
Source of Monetary or Material Support
|
| D. Y. Patil Deemed to be university School of Ayurveda, sector 7, OPD 1, Nerul, Navi Mumbai,400706 |
|
|
Primary Sponsor
|
| Name |
Dr Hetalben Patel |
| Address |
D. Y. Patil Deemed to be university School of Ayurveda, Nerul, Navi Mumbai 400706 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR Hetalben Patel |
D Y Patil Deemed to be University School of Ayurveda |
1st Floor, OPD no. 1, Department of Kayachikitsa, D. Y. Patil University school of Ayurveda, Sector 7, Nerul, Navi Mumbai-400706.
Thane
MAHARASHTRA |
9421493943
hetalpatel1398@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee of school of ayurveda , D. Y. Patil Deemed to be University, Nerul, Navi mumbai. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E00-E89||Endocrine, nutritional and metabolic diseases. Ayurveda Condition: PRAMEHA-PURVARUPAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:, Pathya/Apathya:yes, Pathya:CEREALS/PULSES
Moong
Rakta/shaashti chawal
Jau
Kulatha
Jowari
Bajra
VEGETABLES
Parval
Bhopala
Methi
Palak
Karela
Bottle gourd
Tinduk
Cauliflower/cabbage
Rason
FRUITS
Orange
Sweet lime
Pomegranate
Kharbuja
Bahubheej/Peru
Kapitha
Jambu
VIHARA
Ratrijagran nished
Diwaswap nished , Apathya:AHAR
Sugar
Takra
Dadhi
Taila
Dugdha
Ghrut
Sugarcane juice
Anuppradeshi mamsa
Madhur rasa
Guda
Madira
VIHARA
Swapnashayasanprasang(sleep,bed
rest, sedentary lifestyle)
Diwaswap | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: chitrakadi churna, Reference: ashtanga hrudaya chikitsasthana 12/6, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: tds, Bhaishajya Kal: Antarabhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -koshnajala), Additional Information: classical drug with lifestyle management will be given. |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1)Newly diagnosed patient with Prameha Purvarupa w.r.t prediabetes.
i.e. -HbA1c- 5.7-6.4% or
-FBS- 100-125 mg/dl or
-PPBS- 140-199 mg/dl.
2)Subjects of age group between 20-70yrs (20-70 both inclusive) will be in the inclusive.
3)Both males and females (female- non-lactating and not pregnant) will be in the inclusion.
4)Written consent showing willingness to participate in the study.
5)The patient will be taken according to American Medical Association Criteria for diagnosis of Diabetes Mellitus.
|
|
| ExclusionCriteria |
| Details |
1)Age under 20 years and over 70 years.
2)Type-II DM (NIDDM) with and without complications
3)Type-I DM (IDDM) associated with and without complications
4)Known cases of Diabetes due to endocrinopathies, for example, pheochromocytoma, acromegaly, Cushing’s syndrome, etc.
5)Patients having disorders like carcinoma anywhere in the body or any other major life-threatening disease.
6)Known cases of drug or chemical-induced DM, such as glucocorticoids, thyroid hormone, thiazides, phenytoin, etc.
7)Known cases of Certain genetic syndromes sometimes associated with DM, e.g., Down’s syndrome, Klinefelter’s syndrome, Turner’s syndrome, etc. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in HbA1C levels from baseline, indicating improvement in glycemic control among prediabetes individuals |
follow up will be 30 days for 3 months (90 days) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
reduction in BMI, indicating weight management improvement as part of lifestyle intervention.
improvement in waist to hip ratio. |
measures before the start of intervention at day 0 and final measurements at day 90 to assess changes |
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
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 3 |
|
Date of First Enrollment (India)
|
01/04/2025 |
| 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 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
|
TITLE OF DISSERTATION A RANDOMIZED CLINICAL STUDY TO EVALUATE EFFICACY OF CHITRAKADI CHURNA & LIFESTYLE MANAGEMENT IN PREDIABETES WITH SPECIAL REFERENCE TO HBA1C.
Background
Prediabetes is an intermediate metabolic state between normoglycemia and Type 2 Diabetes Mellitus (T2DM), characterized by impaired fasting glucose (IFG) and/or impaired glucose tolerance (IGT). It is a significant public health concern due to its high prevalence and the risk of progression to T2DM and related complications such as cardiovascular diseases, nephropathy, and neuropathy. Lifestyle modifications, including diet and exercise, are the cornerstone of prediabetes management. However, maintaining long-term adherence to lifestyle changes is challenging for many individuals.
Ayurveda offers several herbal formulations with potential hypoglycemic, insulin-sensitizing, and metabolism-enhancing properties. Chitrakadi Churna, known for its deepana (digestive stimulant) and pachana (carminative) effects, may help improve metabolic function and regulate blood sugar levels. However, there is a lack of robust clinical evidence comparing Chitrakadi Churna with conventional lifestyle interventions for prediabetes management.
Purpose of the Trial
This study aims to evaluate and compare the efficacy of Chitrakadi Churna combined with lifestyle modifications versus lifestyle modifications alone in prediabetes management. Specifically, the objectives are: OBJECTIVES: - PRIMARY OBJECTIVE- • To Study & Compare effect of Chitrakadi Churna and Lifestyle Management In Prediabetes w.s.r to HbA1C. SECONDARY OBJECTIVES- • To Study the Effect of Chitrakadi Churna In The Management Of Prediabetes w.s.r. To HbA1C. • To Study the Effect of Lifestyle Management On Prediabetic Patients w.s.r HbA1C. • To assess the effect of chitrakadi churna & lifestyle management on body mass index (BMI) and waist-to-hip ratio in Prediabetes. RESEARCH QUESTIONS- 1. Is Chitrakadi Churna is effective in themanagement of Prediabetes w.s.r HbA1C? 2. Is the effect of Chitrakadi Churna is significant than lifestyle management in prediabetes w.s.r to HbA1C? HYPOTHESIS- NULL HYPOTHESIS- There is no significant difference between the efficacy of Chitrakadi Churna and lifestyle management in prediabetes w.s.r. HbA1C. ALTERNATIVE HYPOTHESIS- - There is a significant difference between the efficacy of Chitrakadi Churna and lifestyle management in prediabetes w.s.r. HbA1C SUBJECTIVE CRITERIA 1. Prabhutmutrata (polyuria) 2. Atipipasa(polydipsia) 3. Atikhudha(polyphagia) 4. Hastapadataladaha (burning sensation in hand & feet) 5. Nidra adhikya (excessive sleep) 6. Alasya (laziness) 7. Avilmutrata 8. Mukha shosh (dryness in the mouth) 9. Sheet priyata (liking of cold things) 10. Madhuryamaasyata (sweet taste in mouth) OBJECTIVE ASSESSMENT – 1. Weight 2. BMI (Body Mass Index) 3. WAIST-HIP RATIO: - The WHO advises that a healthy WHR is: 0.85 or less for women. 0.9 or less for men. 4. 4.HBA1C 5. FBS (Fasting Blood Glucose) 6. PPBS (Post Prandial Blood Glucose) 7. Fasting Urine sugar 8. Post Prandial Urine sugar. Materials Group A: - chitrakadi churna and lifestyle management Chitraka, Amalaki, Bibhitaki, Haritaki, Daruharidra, Indrayava Dose- 3gm before food with warm water thrice a day. Group B: - lifestyle management Will be suggested to every subject & compliance will be recorded monthly. Sample size: - Considering a 20% dropout rate though a sample size of 82, we proposed to enroll 100 subjects to get 82 evaluable cases. Statistical analysis -All observations will be noted in the observation table. -Depending upon the Observation, Statistical analysis will be done by an appropriate test. -For subjective parameters, Wilcoxon rank-sum test will be applicable -For objective parameters Paired t-test will be applicable. |