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CTRI Number  CTRI/2023/11/060110 [Registered on: 22/11/2023] Trial Registered Prospectively
Last Modified On: 21/11/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Preventive 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Clinical study of Nisha Amalaki extract in Prediabetic with special reference to Prameha. 
Scientific Title of Study   An open randomised control clinical study of Nisha Amalaki extract in Prediabetic with special reference to Prameha. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR SAJIDA D ATTAR 
Designation  PhD SCHOLAR 
Affiliation  APMS AYURVED MAHAVIDYALAYA SION  
Address  SION AYURVED HOSPITAL,NEAR SION RAILWAY STATION, SION, MUMBAI 400022
SION AYURVED HOSPITAL,NEAR SION RAILWAY STATION, SION, MUMBAI 400022
Mumbai
MAHARASHTRA
400022
India 
Phone  8097061246  
Fax  0224072176  
Email  DR.SAJIDAATTAR@YAHOO.COM  
 
Details of Contact Person
Scientific Query  
Name  DR HEMANT PARADKAR 
Designation  PhD SCHOLAR 
Affiliation  APMS AYURVED MAHAVIDYALAYA SION  
Address  SION AYURVED HOSPITAL,NEAR SION RAILWAY STATION, SION, MUMBAI 400022
SION AYURVED HOSPITAL,NEAR SION RAILWAY STATION, SION, MUMBAI 400022
Mumbai
MAHARASHTRA
400022
India 
Phone  9987519315  
Fax    
Email  hemant.paradkar@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR SAJIDA D ATTAR 
Designation  PhD SCHOLAR 
Affiliation  APMS AYURVED MAHAVIDYALAYA SION  
Address  SION AYURVED HOSPITAL,NEAR SION RAILWAY STATION, SION, MUMBAI 400022

Mumbai
MAHARASHTRA
400022
India 
Phone  8097061246  
Fax    
Email  DR.SAJIDAATTAR@YAHOO.COM  
 
Source of Monetary or Material Support  
APMs Ayurved Mahavidyalaya 
 
Primary Sponsor  
Name  DR SAJIDA D ATTAR 
Address  APMS AURVED MAHAVIDYALAYA SION. NEAR SION RAILWAY STATION, SION, MUMBAI 400022 
Type of Sponsor  Other [SELF] 
 
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 SAJIDA D ATTAR  APMS AYURVED MAHAVIDYALA  OPD 9 AND 10 AYURVED MAHAVIDYALAYA, SION
Mumbai
MAHARASHTRA 		 8097061246

DR.SAJIDAATTAR@YAHOO.COM 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ayurvidya Prasarak Mandals IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E70-E88||Metabolic disorders. Ayurveda Condition: PRAMEHAH, (2) ICD-10 Condition:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: PRAMEHA-PURVARUPAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: NISHA AMALAKI, Reference: ASHTANG HRUDAYA UTARA TANTRA 40 CHAPTER , 48/40, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -WATER), Additional Information: -
2Comparator Arm (Non Ayurveda)-TAB METFORMIN1) Medicine Name: TAB METFORMIN, Reference: NA, Route: Oral, Dose: 500(mg), Frequency: twice daily, After breakfast and dinner with water Duration: 3 Months
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)Having IDRS score more than 50.
2)HbA1c level of 5.7-6.4%
3)A fasting blood Sugar level (FBS) of 110-125 mg/dL ; (fasting is done as no caloric intake for at least 8 hours.)
4)A 2-hour Blood Sugar level (PPBS) of 140 to 199 mg/dL .
 
 
ExclusionCriteria 
Details  1.Exclusion criteria included people currently using oral hypoglycemic agents (OHAs); those reporting prior use of medication to treat diabetes mellitus.
2.Type ll Diabetes Mellitus (NIDDM)
3.Type l Diabetes Mellitus (IDDM)
4.Subjects giving history of signicant cardiovascular event < 12 weeks prior to study
5.Subjects with known Chronic Infectious Disease, such as active Tuberculosis, Hepatitis B or C, or HIV.
6.Pregnant female and lactating mother
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate efficacy of Nisha Amalaki extract on symptoms of prediabetic as per subjective and objective assessment mentioned in synopsis  at every follow up 15th day, 30th day, 45th day, 60th day, 75 th day, 90th day 
 
Secondary Outcome  
Outcome  TimePoints 
To compare mode of action of nisha amalaki extract & tab metformin in management of prediabetis
to check safety or adverse effect of the drugs 		 at every follow up 15th day, 30th day, 45th day, 60th day, 75 th day, 90th day  
 
Target Sample Size   Total Sample Size="124"
Sample Size from India="124" 
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 4 
Date of First Enrollment (India)   08/12/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  08/12/2023 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  through email dr.sajidaattar@yahoo.com

  6. For how long will this data be available start date provided 31-12-2023 and end date provided 31-12-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

For the prevention of Diabetes specially type 2 diabetes and related complication it is a need to control this hyperglycaemia stage not only after diagnosis of type 2 diabetes mellitus but even before in prediabetes stage which is developed due to insulin resistance. Prediabetes is an intermediate step before manifestation of full blown DM. Prediabetes is an intermediate stage between normal and diabetes state wherein blood glucose levels are higher than normal but not high enough to be considered as diabetic.Prediabetes is a state of high risk for developing Diabetes with 5 to 10% cases converting to Diabetes per annum.This fact itself triggered the need of review of this disease. Prediabetes means a ‘pre diagnosis of diabetes’.Every third person who tested their blood sugar in Mumbai has prediabetes, according to a five-year data analysis of 2.9 lakh patients by a national laboratory. According to a study published in the Indian Journal of Medical Research in 2018, the estimated prevalence of prediabetes in India is 14% - and that’s just those who have been tested .Effective intervention at prediabetic step would help stop/slow progression to DM..

As the name suggests, prediabetes is a precursor or an early warning system to diabetes. Various herbs mentioned in the Ayurveda literature have been found to be useful for reduction in blood sugar, decrease in insulin resistance, and improvement in beta cell activity .Etiology of diabetes is multifactorial and multi targeted herbal drugs would be comparatively safer than modern drugs and may be used in management of prediabetes and prevention of progression to diabetes.Therefore, this study aimed to see whether Nishaamalaki can reduce the conversion from prediabetes to type 2 diabetes mellitus.

Combination of Nisha amalaki formulation has tridoshahara property but specically Kaphahara property. Its acts on vitiated Kapha, Meda and Kleda, It has capacity to improve tone of saptadhatus and reduces Dhatushaithilya. Due to its Deepan and Pachan properties, Dhatri nisha Churna works on Jatharagni and Dhatwagni, which reduces the Ama and kleda present in the body. It improves Dhatwagni which helps to improve disturbed metabolism. Nisha amalaki having Deepan, Pachan and Anuloman properties. By Deepan, Pachan, Anuloman properties it works on srotodushti and glucose metabolism. Due to its Ruksha Guna this kalpa is doing Kleda Shoshana which is useful in Samprapti bhanga of Prameha that is Prediabetic.

 
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