| CTRI Number |
CTRI/2023/08/056952 [Registered on: 25/08/2023] Trial Registered Prospectively |
| Last Modified On: |
29/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study to evaluate the efficacy of Dhanyamla Dhara in Diabetic Neuropathy |
|
Scientific Title of Study
|
A Randomised Open Labelled Controlled Clinical Study to evaluate the efficacy of Dhanyamla Dhara in Diabetic Neuropathy |
| 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 Vaidyanath V S |
| Designation |
PG Scholar |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research Hospital Bangalore |
| Address |
OPD No.8
Dept. of Panchakarma
Sri Sri College of Ayurvedic Science and Research Hospital
21st KM Kanakapura Road
Udayapura PO
Bangalore
Bangalore
KARNATAKA
560082
India |
| Phone |
9495593392 |
| Fax |
|
| Email |
drvaidyanathvs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prajwal Narayan |
| Designation |
Professor |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research Hospital Bangalore |
| Address |
OPD No.8
Dept. of Panchakarma
Sri Sri College of Ayurvedic Science and Research Hospital
21st KM Kanakapura Road
Udayapura PO
Bangalore
Bangalore
KARNATAKA
560082
India |
| Phone |
8951072206 |
| Fax |
|
| Email |
prajwalayurveda@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prajwal Narayan |
| Designation |
Professor |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research Hospital Bangalore |
| Address |
OPD No.8
Dept. of Panchakarma
Sri Sri College of Ayurvedic Science and Research Hospital
21st KM Kanakapura Road
Udayapura PO
Bangalore
Bangalore
KARNATAKA
560082
India |
| Phone |
8951072206 |
| Fax |
|
| Email |
prajwalayurveda@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Sri College of Ayurvedic Science and Research Hospital, Bangalore |
|
|
Primary Sponsor
|
| Name |
DR VAIDYANATH V.S |
| Address |
OPD No.8
Dept. of Panchakarma
Sri Sri College of Ayurvedic Science and Research Hospital
21st KM Kanakapura Road
Udayapura PO
Bangalore |
| 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 Vaidyanath V S |
Sri Sri College of Ayurvedic Science and Research Hospital Bangalore |
OPD No.8
Dept. of Panchakarma
Sri Sri College of Ayurvedic Science and Research Hospital
21st KM Kanakapura Road
Udayapura PO
Bangalore
Bangalore
KARNATAKA |
9495593392
drvaidyanathvs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI SRI INSTITUTIONAL ETHICAL COMMITTEE BENGALURU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G64||Other disorders of peripheral nervous system. Ayurveda Condition: PRAMEHA-UPADRAVAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | dravasvedaH, दà¥à¤°à¤µà¤¸à¥à¤µà¥‡à¤¦à¤ƒ | (Procedure Reference: Charaka Samhita Sutra Sthana Chapter 27, Procedure details: Dhanyamla Dhara 1 time per day for 7 days)
(1) Medicine Name: Dhanyamla, Reference: Sahasrayoga, Route: Topical, Dosage Form: Dravaka, Dose: 5000(ml), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | takradhArA, तकà¥à¤°à¤§à¤¾à¤°à¤¾ | (Procedure Reference: Dhara Kalpa, Procedure details: Takra Dhara 1 time per day for 7 days)
(1) Medicine Name: Takra, Reference: Charaka Samhita Sutra Sthana Chapter 27, Route: Topical, Dosage Form: Dravaka, Dose: 5000(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Metabolically stable diabetic subjects with symptomatic Diabetic Peripheral Neuropathy.
2.Subjects of all gender between the age group of 30-65 years.
3.Subjects fulfilling the diagnostic criteria.
4.Subjects whose HbA1C is between 6.5 to 10%.
|
|
| ExclusionCriteria |
| Details |
1.Subjects where HbA1C >10% and <6.5%.
2.Subjects suffering from Type-1 Diabetes or Gestational Diabetes.
3.Pregnant and lactating women.
4.Subjects suffering from infectious diseases and non-healing ulcer/ ulcers of foot.
5.Any systemic illness that can interfere with the course of treatment.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment of the patients condition will be done based on
1.Changes in Michigan Neuropathy Screening Instrument (MNSI) Questionnaire score
2.Changes in Toronto Neuropathy Clinical Scale (TCNS) Score
3.Changes in Visual Analog Scale (VAS)
|
Before intervention 0th day
After intervention 7th day
Follow up 14th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Changes in FBS value
2. Changes in PPBS value |
Before intervention 0th day
After intervention 7th day
Follow up 14th day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
Modification(s)
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
01/09/2023 |
| 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
|
Dhanyamla is a medicine which can be used as multifaceted treatment. It is Jeevana (sustainer of life), Daha Nashana (mitigate burning sensation), Vata Kapha Nashaka (pacify vata & kapha), Trishna hara (mitigate thirst), Deepana (enhance digestion), Jarana (digestive), Sramahara (relieves fatigue) and Klamahara (relieves exhaustion). Since the symptoms of Diabetic Peripheral Neuropathy such as pain, burning sensation, numbness and tingling sensation can be correlated to the involvement of vitiated Vata and Kapha, Dhanyamla, having properties of Vata Kapha nashaka, Dahahara, Trisnahara, etc can be used for the treatment of Diabetic Peripheral Neuropathy. Hence, Sarvanga dhara by Dhanyamla in Diabetic Peripheral Neuropathy is choosen for this study. |