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CTRI Number  CTRI/2025/12/098652 [Registered on: 08/12/2025] Trial Registered Prospectively
Last Modified On: 05/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [THERAPEUTIC]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to find out if Nisha-Amalaki Ghan capsules work with Metformin to manage Type 2 Diabetes (Madhumeha). 
Scientific Title of Study   A Randomised Controlled Trial to Evaluate the Add-on Efficacy of Nisha-Amalaki Ghan Capsule with Metformin versus D4 combination Ghan Capsule with Metformin in the Management of Aavaranjanya Madhumela (Type 2 Diabetes Mellitus) 
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 Kirti 
Designation  MD Scholar 
Affiliation  All India Institute Of Ayurveda 
Address  Department Of Kayachikitsa 6th Floor Of Academic Block All India Institute Of Ayurveda ,Gautampuri,Sarita Vihar, New Delhi
Department Of Kayachikitsa 6th Floor Of Academic Block All India Institute Of Ayurveda ,Gautampuri,Sarita Vihar, New Delhi
South
DELHI
110076
India 
Phone  9813149335  
Fax    
Email  kirtiparashar560@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Raja Ram Mahto 
Designation  Associate Professor 
Affiliation   
Address  Department Of Kayachikitsa 6th Floor Of Academic Block All India Institute Of Ayurveda ,Gautampuri,Sarita Vihar, New Delhi

South
DELHI
110076
India 
Phone  8877033663  
Fax    
Email  Mahtorajaram@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Kirti 
Designation  MD Scholar 
Affiliation  All India Institute Of Ayurveda 
Address  Department Of Kayachikitsa 6th Floor Of Academic Block All India Institute Of Ayurveda ,Gautampuri,Sarita Vihar, New Delhi
Department Of Kayachikitsa 6th Floor Of Academic Block All India Institute Of Ayurveda ,Gautampuri,Sarita Vihar, New Delhi

DELHI
110076
India 
Phone  9813149335  
Fax    
Email  kirtiparashar560@gmail.com  
 
Source of Monetary or Material Support  
All India Institute Of Ayurveda ,Gautampuri,Sarita Vihar, New Delhi 110076 
 
Primary Sponsor  
Name  All India Institute Of Ayurveda 
Address  Department Of Kayachikitsa 6TH Floor Of Academic Block All India Institute Of Ayurveda ,Gautampuri,Sarita Vihar, New Delhi 110076 
Type of Sponsor  Research institution and hospital 
 
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 Kirti   All India Institute Of Ayurveda  Department Of Kayachikitsa 6th Floor Of Academic Block All India Institute Of Ayurveda ,Gautampuri,Sarita Vihar, New Delhi 110076
South
DELHI 		 9813149335

kirtiparashar560@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  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 ArmDrugOther than Classical(1) Medicine Name: Nishamalaki Ghan Capsule , Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 12 Weeks, anupAna/sahapAna: Yes(details: Luke warm water ), Additional Information: -along with Metformin tablet - 500 mg bid after food
2Comparator ArmDrugOther than Classical(1) Medicine Name: D4 Combination Ghan Capsule , Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 12 Weeks, anupAna/sahapAna: Yes(details: -Luke warm water ), Additional Information: along with Metformin Tablet - 500mg Bid After food
 
Inclusion Criteria  
Age From  31.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Adults aged 31-60 years
2.Patients with classical signs and symptoms of Madhumeha/T2DM
3.Fasting blood sugar (FBS)greater than or equal to 126 mg/dl up to 180 mg/dl and/or
4.Postprandial blood sugar (PPBS) greater than or equal to 200 mg/dl up to 240 mg/dl and
5. Glycosylated haemoglobin (HbA1C) greater than or equal to 6.5% - 9%
6. The patient is willing to give consent.
7. Patient with BMI greater than or equal to 18 to less than or equal to 30
8. Patients diagnosed with Type 2 Diabetes Mellitus within the last 3 years and currently on metformin therapy minimum of under 3 month. .
NOTE (In the above-given criteria (3-4), one should be present and raised HbA1C is necessary.)
 
 
ExclusionCriteria 
Details  1.Patients diagnosed with Type 1 Diabetes Mellitus or those who are insulin-dependent and currently receiving insulin therapy.
2.Patients with uncontrolled hypertension (more than 160/100 mm of Hg), and uncontrolled diabetes (fasting blood sugar level more than 180 mg/dl and postprandial blood sugar level more than 240 mg/dl or HbA1c more than 9% )
3.Patients with chronic complications related to diabetes, including microvascular (e.g., retinopathy, nephropathy, and neuropathy) and macrovascular complications (e.g., coronary artery disease, peripheral vascular disease, cerebrovascular disease).
4.Pregnant women/lactating mothers.
5.Patient with Hypothyroidism.
6.Patients were reported to be hypersensitive to any of the proposed trial drugs.
7.Participation in other clinical studies in the past 12 weeks
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Evaluation of the add-on efficacy of Nishamalki Ghan Capsule with Metformin compared to Metformin with D4 combination Ghan Capsule by assessing the reduction in HbA1c levels over 12 weeks.  Evaluation of the add-on efficacy of Nishamalki Ghan Capsule with Metformin compared to Metformin with D4 combination Ghan Capsule by assessing the reduction in HbA1c levels over 12 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in classical signs & symptoms like fatigue frequent urination & thirst of Madhumeha
Reduction in Fasting Blood Sugar & Postprandial Blood Sugar levels
Improvement in Lipid Profile levels & Urine routine & Microscopic
Improvement in the quality of life of the patient using the SF 36 fatigue scale 		 Outcome will be assessed at baseline, 4th week 8th week 12th week & 18th week 
 
Target Sample Size   Total Sample Size="96"
Sample Size from India="96" 
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   N/A 
Date of First Enrollment (India)   25/12/2025 
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 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  
Title
A Randomised Controlled Trial to Evaluate the Add on Efficacy of Nisha Amalaki Ghan Capsule with Metformin versus D4 Combination Ghan Capsule with Metformin in the Management of Aavaranjanya Madhumeha Type 2 Diabetes Mellitus
Introduction
Madhumeha, described in Ayurveda as a subtype of Prameha, correlates with Type 2 Diabetes Mellitus in modern medicine. It is a metabolic disorder characterised by increased blood sugar levels resulting from insulin resistance or inadequate insulin secretion. Ayurveda explains Madhumeha as a disease of Kapha and Vata imbalance, primarily caused by the obstruction of Vata by Kapha or Meda, known as Aavaran. This results in impaired metabolism and improper utilisation of glucose. The condition corresponds to Aavaranjanya Madhumeha, in which deranged Kapha and Meda obstruct the normal function of Vata leading to Prameha Lakshanas such as polyuria, polyphagia, and fatigue.
The management of Type 2 Diabetes Mellitus in modern medicine primarily relies on oral hypoglycaemic agents such as metformin. However, long-term monotherapy often fails to maintain adequate glycaemic control and may produce side effects. Ayurveda provides several herbal formulations that improve glucose metabolism, enhance insulin sensitivity, and rejuvenate the body tissues. Nisha Amalaki, a classical formulation consisting of Curcuma longa and Emblica officinalis, has proven anti-diabetic, antioxidant, and anti-inflammatory properties. The D4 combination is a polyherbal Ghan formulation comprising potent herbs known for their hypoglycaemic and rejuvenating effects. Hence, the present study aims to evaluate and compare the add-on efficacy of Nisha Amalaki Ghan capsule and D4 combination Ghan capsule when used along with metformin in patients of Aavaranjanya Madhumeha.
Objectives
The primary objective is to evaluate the add-on efficacy of Nisha Amalaki Ghan capsule and D4 combination Ghan capsule with metformin in patients with Aavaranjanya Madhumeha or Type 2 Diabetes Mellitus. The secondary objectives include comparison of clinical symptom improvement, assessment of fasting and postprandial blood glucose levels, glycosylated haemoglobin, lipid profile, and overall quality of life.
Materials and Methods
This will be a randomised, controlled, parallel-group clinical trial conducted in adult patients diagnosed with Type 2 Diabetes Mellitus fulfilling the diagnostic criteria of Aavaranjanya Madhumeha. A total of 60 participants will be selected and randomly allocated into two groups with 30 participants in each group.
Group A will receive Nisha Amalaki Ghan capsule 500 mg twice daily along with metformin 500 mg twice daily. Group B will receive D4 combination Ghan capsule 500 mg twice daily along with metformin 500 mg twice daily. The total duration of the intervention will be 60 days.
The selection of patients will be based on inclusion and exclusion criteria. Inclusion criteria include diagnosed cases of Type 2 Diabetes Mellitus aged between 30 and 60 years with mild to moderate symptoms of Madhumeha. Exclusion criteria include patients with insulin-dependent diabetes mellitus, diabetic complications, or any major systemic illness.
The trial will be conducted following Good Clinical Practice guidelines with informed consent obtained from all participants. Randomisation will be done using a computer-generated random number table, and allocation will be concealed until assignment.
Clinical assessment will be carried out at baseline, after 30 days, and after 60 days of treatment. The parameters assessed will include fasting blood sugar, postprandial blood sugar, glycosylated haemoglobin, lipid profile, and subjective symptoms of Madhumeha as described in classical texts.
Assessment Criteria
The primary outcome measures will include change in fasting blood sugar, postprandial blood sugar, and glycosylated haemoglobin. The secondary outcome measures will include change in lipid profile, body weight, and subjective parameters such as excessive urination, thirst, fatigue, and dryness of mouth.
Statistical Analysis
The collected data will be expressed as mean and standard deviation. Appropriate statistical tests such as paired and unpaired t-tests will be used to compare the intra-group and inter-group differences. A p-value less than 0.05 will be considered statistically significant.
Expected Results
It is expected that both the formulations, when administered along with metformin, will show significant improvement in glycaemic control and clinical symptoms compared to metformin alone. The Nisha Amalaki Ghan capsule group may demonstrate better efficacy due to the synergistic antioxidant and metabolic enhancing properties of Curcuma longa and Emblica officinalis.
Discussion
Ayurvedic literature describes Madhumeha as a disease caused by improper lifestyle, dietary habits, and suppression of natural urges, leading to derangement of Kapha, Meda, and Vata. The concept of Aavaranjanya Madhumeha explains the pathogenesis as obstruction of Vata by Kapha and Meda, leading to impaired metabolism. Nisha Amalaki is indicated in Prameha for its Kapha Medohara and Rasayana properties. Curcuma longa possesses curcuminoids that enhance insulin sensitivity, reduce oxidative stress, and improve lipid metabolism. Emblica officinalis rejuvenates pancreatic function, reduces glycosylated haemoglobin, and improves digestion.
The D4 combination, consisting of herbs like Gymnema sylvestre, Syzygium cumini, Momordica charantia, and Tinospora cordifolia, has hypoglycaemic, antioxidant, and immunomodulatory actions. These herbs improve glucose uptake, stimulate pancreatic beta-cell regeneration, and reduce insulin resistance. Hence, both formulations are expected to be beneficial in correcting doshic imbalance and restoring normal glucose metabolism.
Ethical Considerations
The study will be conducted after obtaining ethical clearance from the Institutional Ethics Committee. Written informed consent will be obtained from all participants prior to inclusion. Confidentiality of participant data will be maintained throughout the study. Participants will have the right to withdraw from the study at any stage without penalty.
Conclusion
This randomised controlled trial aims to scientifically evaluate the add-on efficacy of Nisha Amalaki Ghan capsule and D4 combination Ghan capsule with metformin in patients of Aavaranjanya Madhumeha. The study will help to validate Ayurvedic concepts of Aavaran and Prameha in modern clinical terms and provide an integrative therapeutic approach to Type 2 Diabetes Mellitus. If successful, these herbal formulations may serve as safe, effective, and economical adjuncts to conventional anti-diabetic therapy, thereby improving overall treatment outcomes and patient quality of life.
 
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