| CTRI Number |
CTRI/2024/02/062264 [Registered on: 05/02/2024] Trial Registered Prospectively |
| Last Modified On: |
27/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
To observe Acanthosis nigricans (skin discolouration) in patients of Prameha. |
|
Scientific Title of Study
|
An observational study of twak vaivarnya (Acanthosis nigricans) in prameha |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pallavi Bhalchandra Raut |
| Designation |
PG scholar |
| Affiliation |
Tilak ayurved mahavidyalaya, Pune |
| Address |
Tilak Ayurved Mahavidyalaya, rognidan department,Rasta
Peth,Pune Tarachand hospital,Rasta peth , pune
Pune
MAHARASHTRA
411011
India
Tarachand hospital,rasta peth,Pune-411011
Pune
MAHARASHTRA
411011
India |
| Phone |
7887595392 |
| Fax |
|
| Email |
pallaviraut879@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aishwarya Ranade |
| Designation |
Assistant professor MD PhD Rognidan |
| Affiliation |
Tilak Ayurved Mahavidyalaya , Pune |
| Address |
Tilak Ayurved Mahavidyalaya, rognidan department,Rasta
Peth,Pune Tarachand hospital,Rasta peth , pune
Pune
MAHARASHTRA
411011
India
Tarachand hospital,rasta peth, Pune-411011
Pune
MAHARASHTRA
411011
India |
| Phone |
9423876727 |
| Fax |
|
| Email |
ashmr81@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aishwarya Ranade |
| Designation |
Assistant professor MD PhD Rognidan |
| Affiliation |
Tilak Ayurved Mahavidyalaya , Pune |
| Address |
Tilak Ayurved Mahavidyalaya, rognidan department,Rasta
Peth,Pune Tarachand hospital,Rasta peth , pune
Pune
MAHARASHTRA
411011
India
Tarachand hospital,rasta peth, Pune-411011
Pune
MAHARASHTRA
411011
India |
| Phone |
9423876727 |
| Fax |
|
| Email |
ashmr81@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tilak Ayurvedic Mahaviyalay,Seth Tarachand Ramnath Charitable Ayurvedic Hospital,Pune |
|
|
Primary Sponsor
|
| Name |
Tilak Ayurved Mahavidyalaya |
| Address |
Tilak Ayurved Mahavidyalaya,Rasta peth,Pune |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Pallavi Bhalchandra Raut |
Tilak Ayurved Mahavidyalaya |
Tilak Ayurved
Mahavidyalaya,Rasta
peth,Pune. Rognidan Department Seth
Tarachand Hospital. Lab number 18
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
7887595392
pallaviraut879@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| TILAK AYURVED MAHAVIDYALAYA AND SHETH TARACHAND RAMNATH CHARITABLE HOSPITAL INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E00-E89||Endocrine, nutritional and metabolic diseases. Ayurveda Condition: PRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Individuals belonging to age group between 20-70 years of age.3.Participants will be selected irrespective of religion, marital status, economical status.3.Known case of Prameha. |
|
| ExclusionCriteria |
| Details |
Participants having upadravas of Prameha e.g. Prameha pidaka, Vidradhi, Shwasa, jwara, puti Mansa |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the proportion of participants having Prameha with twak vaivarnya (acanthosis nigricans). |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine gender wise proportion of participants of Prameha with twak vaivarnya. |
18 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/03/2024 |
| 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 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
|
Acanthosis nigricans is a dermatological manifestation often serves as a visual indicator of underlying metabolic intricacies. It is characterized by darkened, thick velvety skin in body folds and creases. This hyperkeratosis and pigmentation are distributed on neck, axillae, antecubital and popliteal fossae, and groin folds. The neck is mainly affected in acanthosis nigricans [1]Acanthosis nigricans is a skin condition occurs as a result of Insulin resistance. In Ayurveda Prameha is described with symptoms similar to diabetes like increased amount of vitiated (turbid) urine with deranged colour. The term ‘Prameha’ has two parts. ‘Pra’ means abundant, and ‘Meha’ meaning ‘passing of large quantity of urine. In Ayurveda texts there is no direct reference of acanthosis nigricans; therefore, with curiosity to study about ayurvedic perspective of twak vaivarnya (acanthosis nigricans) and observe occurrence of twak vaivarnya (acanthosis nigricans) in Prameha topic chosen with title is An observational study of twak vaivarnya (acanthosis nigricans) in Prameha. |