| CTRI Number |
CTRI/2025/01/079572 [Registered on: 27/01/2025] Trial Registered Prospectively |
| Last Modified On: |
26/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Therapeutic Clinical] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Bhumyamalaki Swarasa and Nisha Amalaki Churna in the management of Metabolic Syndrome w.s.r. Medodushti |
|
Scientific Title of Study
|
Comparative study to evaluate the efficacy of Bhumyamalaki Swarasa and Nisha Amalaki Churna in the management of Metabolic Syndrome w.s.r. Medodushti- A randomized controlled open clinical trial |
| 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 Prachi Brahma |
| Designation |
MD Scholar (Kayachikitsa) |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
PG Department of Kayachikitsa, Chaudhary Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, Najafgarh, South West Delhi 110073 India
South West
DELHI
110073
India |
| Phone |
9834787922 |
| Fax |
|
| Email |
prachibrahma1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yogesh Kumar Pandey |
| Designation |
Associate Professor |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
PG Department of Kayachikitsa, Chaudhary Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, Najafgarh, South West Delhi 110073 India
South West
DELHI
110073
India |
| Phone |
9013858523 |
| Fax |
|
| Email |
dryogeshpandey@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yogesh Kumar Pandey |
| Designation |
Associate Professor |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
PG Department of Kayachikitsa, Chaudhary Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, Najafgarh, South West Delhi 110073 India
South West
DELHI
110073
India |
| Phone |
9013858523 |
| Fax |
|
| Email |
dryogeshpandey@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar South West Delhi 110073 India |
|
|
Primary Sponsor
|
| Name |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar South West Delhi 110073 India |
| Type of Sponsor |
Government medical college |
|
|
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 Prachi Brahma |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
PG Department of Kayachikitsa, Chaudhary Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, Najafgarh, South West Delhi 110073 India
South West
DELHI |
9834787922
prachibrahma1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC - CBPACS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E889||Metabolic disorder, unspecified. Ayurveda Condition: MEDOVAHASROTODUSHTIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Bhumyamalaki Swarasa , Reference: Yogratnakar Uttarardha Prameha Chikitsa adhyaya Adhyaya 38, Route: Oral, Dosage Form: Swaras/ Juice, Dose: 20(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: Prakshep dravya Maricha Churna | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Nisha Amalaki Churna , Reference: Ashtang Hridaya Uttarasthana Prameha Chikitsa adhyaya Adhyaya 12 , Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Amalaki Swarasa 20 ml and Madhu ), Additional Information: Nisha Churna 3gm will be administered along with Anupana of Amalaki Swarasa 20 ml and Madhu |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients who met the criteria given by NCEP ATP III
Waist circumference over 40 inches in men or 35 inches in women
Blood pressure over 130/85 mm of Hg
Fasting triglyceride level over 150mg/dl
Fasting high density lipoprotein cholesterol level less than 40mg/dl in men or 50mg/dl in women
Fasting blood sugar over 100mg/dl
2 Homeostatic Model Assesment Insulin Resistant HOMA-IR Score less than 2.9
3 Patients having age between 21 to 60 years with irrespective of gender
4 Subjects who are able to take medicine orally
5 Subjects who are willing to sign the informed consent
|
|
| ExclusionCriteria |
| Details |
1 Fasting blood sugar more than 140 mg/dl
2 Blood Pressure over more than 140/90 mm of Hg
3 Type I and Type II Diabetes mellitus with major complications such as Heart Disease and Stroke Diabetic Nephropathy,Diabetic Retinopathy,Peripheral Neuropathy
4 Systemic illness such as tuberculosis, carcinoma and patient having the history of Myocardial infarction or unstable angina
5 Patient having major renal or liver disorders
6 Lactating mothers and pregnant females
7 Substance abusers such as alcohol
8 Subjects who are registered in any other research project
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in HOMA-IR Score |
Day 0 and Day 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction in the levels of
Sr. Triglyceride
Sr. HDL-C
HbA1c
Blood Pressure
Waist Circumference
along with improvement in the clinical features of Medodushti
Dhatusamyata and Vikaropshaman |
90 days |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
10/02/2025 |
| 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="6"
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
|
Meda is one of the seven dhatus present in the body. The term Medodushti comprises of two terms Medas ( Sneha of body) and Dushti ( Vitiation from its normal physiology). Medodushti is defined as vitiation in Prakrit Karya of Medo Dhatu. According to Acharya Charaka Nidana of Medovaha Strotodushti are non exercise, sleep during day time, excess intake of oily and fatty substances in the diet, drinking of alcoholic drinks. The person with Medodushti will have Kshudra Shwas (breathlessness), Trishna (increased thirst), Daurgandhya (bad smell of body), Kshudha Atimatra (Excessive hunger), Nidradhikya (Excessive sleep), Swedadhikya (Excessive sweating), Alpa Prana (fatigue). Medodushti is well corelated with Metabolic Syndrome. Insulin resistance is a characteristic feature of type 2 Diabetes and is central to the diagnosis of Metabolic Syndrome, which encompasses the different clinical abnormalities and tends to congregate in patients with Insulin resistance, Hypertension, Central obesity, Lipid abnormalities and Prothrombotic state. According to NCEP ATP III definition, Metabolic Syndrome is present if three or more of the following five criteria are met - Waist circumference over 40 inches (men) or 35 inches (women) , Blood Pressure over 130/85 mm of Hg , Fasting Triglyeceride level over 150 mg/dl , Fasting High Density Lipoprotein (HDL) Cholesterol level less than 40 mg/dl (men) or 50mg/dl (women) and Fasting Blood Sugar level over 100 mg/dl. The Prevalence of Metabolic Syndrome is significant in men (54.8%) compared to women (45.2%). Patients in the age group 51-60 years were found to be more affected with Metabolic Syndrome. The present study aims to evaluate the comparative effect of Bhumyamalaki Swarasa and Nisha Amalaki Churna in the management of Metabolic Syndrome ~ Medodushti. The total number of patients is 52, 26 in each group. In group A, Bhumyamalaki Swarasa will be administered in a dose of 20 ml once in a day early morning empty stomach. In group B, Nisha Amalaki Churna will be administered in a dose of 3 gm twice daily with Madhu (honey) morning and evening one hour before meal. The design of the study is single centered , open label , randomized comparative and interventional study. |