| CTRI Number |
CTRI/2025/02/080392 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
10/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of Devdaru Kwath on Madhumeha (Diabetes Mellitus) |
|
Scientific Title of Study
|
Efficacy of Devdaru Kwath in reducing Blood Sugar as a Upshaya in Madhumeha ( Diabetes Mellitus ) A Pragmatic Randomized Control 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 |
Ankit Jha |
| Designation |
PG Scholar |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
PG Department of Rog Nidan Evum Vikriti Vigyan, Chaudhary Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, Najafgarh,New Delhi 110073
South West
DELHI
110073
India |
| Phone |
08851112045 |
| Fax |
|
| Email |
ankitjha2358@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashok Kumar Madan Singh |
| Designation |
Associate Professor |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
PG Department of Rog Nidan Evum Vikriti Vigyan, Chaudhary Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, Najafgarh,New Delhi 110073
South West
DELHI
110073
India |
| Phone |
9899867606 |
| Fax |
|
| Email |
ashokdagar01@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashok Kumar Madan Singh |
| Designation |
Associate Professor |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
PG Department of Rog Nidan Evum Vikriti Vigyan, Chaudhary Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, Najafgarh,New Delhi 110073
South West
DELHI
110073
India |
| Phone |
9899867606 |
| Fax |
|
| Email |
ashokdagar01@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chaudhary Brahm Prakash Ayurved Charak Sansthan , Khera Dabar, Najafgarh, New Delhi ,India, Pincode 110073 |
|
|
Primary Sponsor
|
| Name |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
Khera Dabar, Najafgarh,New Delhi 110073 |
| 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 Ankit Jha |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
PG Department of Rog Nidan Evum Vikriti Vigyan, Chaudhary Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, Najafgarh,New Delhi 110073
South West
DELHI |
8851112045
ankitjha2358@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:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Devdaru Kwath, Reference: Bhavpraksh Samhita, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: -Devdaru Kwath will be given as Upshaya along with standard treatment Protocol for Diabetes Mellitus. | | 2 | Comparator Arm (Non Ayurveda) | | - | Standard treatment Protocol for Diabetes Mellitus | Patient will continue taking standard treatment prescribed for Type-2 Diabetes Mellitus |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients of both the gender between age of 18 to 65 years
2 Patients with fasting blood sugar more than equal to 126 mg per dl
3 Patients with PPBS more than 200mg per dl
4 Patients with classical signs and symptoms of Type2 Diabetes Mellitus
5 Patients with HbA1c more than 6 point 5 percent and less than 10 percent
6 Patients willing to provide consent to participate in the study |
|
| ExclusionCriteria |
| Details |
1 Pregnant women and lactating mothers
2 Patients with serious hepatic cardiac or renal disorders or any chronic illness
3 Patients diagnosed with Type-1 Diabetes Mellitus |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in Blood Sugar levels |
90 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in Clinical Features of Madhumeha Alongwith Lower levels of FBS , PPBS, HbA1c |
90 DAYS |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
03/03/2025 |
| 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
|
Madhumeha is the disease of metabolic derangement and genetic predisposition related with each
individual body constitution and systemic consideration. In Ayurveda Madhumeha has been described as
one among the 20 types of Prameha & is a sub-type of Vatika Prameha in which patient passes excessive
amounts of urine that tastes & looks like honeyi.iiIn Madhumeha the properties of urine is similar with that
of Madhu i.e. of Kashaya and Madhura rasa, rooksa (dry) guna and honey like colour. Madhumeha is well described in ayurvedic major and minor samhitas. Though it is a subtype of Vataja
Prameha it has more prevalence in the society and may be compared to diabetes mellitus of the modern
medical sciences .The main factors involved in the pathogenesis of Prameha are Vata, Pitta, Kapha, Meda
and Oja. Therefore the treatment of this disease should be Tridosha shamaka chikitsa along with
Brimhan-Karshana and Rasayana chikitsa. Acharya Sushurt has narrated that all the Pramehas finally
convert into Madhumeha, if not treated at the primary stage. Diabetes mellitus is a chronic, debilitating disease characterized by hyperglycemia, insulin resistance, and
impaired insulin secretion. As per International Diabetes Federation’s (IDF) fifth diabetes atlas, India’s
prevalence of diabetes among 20-79 year olds is 9.2%. India is just second to China. Due to increase in prevalance of Type-2 DM in society and day by day increasing incidence of primary
and secondary drug failures, it would be effective to introduce a drug as Upshaya along with the standard
prescription prescribed by the physician.According to Vachaspatyam Upshaya word is derived from
Upa+Shi-Ach (Samipashayane). According to Vaidyaka sabdha sindhu Vyadhi jnana heto is Upshaya.
Upshaya word involves the factors which bring about happiness (Sukhanubandha) either by acting directly
against the cause of the disease or the disease itself. According to Amarakosha it indicates permanent
relief but not temporary. As Devdaru has properties opposite to that of Kapha and Vata dosha it would be effective in reducimg
blood sugar as it is said to be Kaphavataghna , Bhavprakash Nighantu , Kaiyedev Nighantu, Dhanvantari
Nighantu has mentioned Devdaru as Pramehaghna, So the study to evaluate the efficacy of Devdaru Kwath as a Upshaya without disturbing the standard
treatment protocol would be very helpful to asses the hypoglycemic effect of Devdaru as an adjuncture
therapy in the form of Upshaya. There is no such study conducted which involves the assessment of Madhumehi patients on
the basis of Upshaya. This study will help to analyze that whether Devdaru kwath as a
Upshaya has hypoglycemic effect or not without disturbing the standard prescription
prescribed by a physician. |