FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/06/089142 [Registered on: 19/06/2025] Trial Registered Prospectively
Last Modified On: 18/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [INTERVENTIONAL ]  
Study Design  Single Arm Study 
Public Title of Study   DHATTURA TAILA ABHYANGA (MASSAGE) IN SUPTHATA  
Scientific Title of Study   A CLINICAL STUDY ON THE EFFECT OF DHATTURA TAILA ABHYANGA IN SUPTHATA  
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 PRATIBHA Y CHAKRASALI  
Designation  PG STUDENT  
Affiliation  KVG AYURVEDA MEDICAL COLLEGE AND HOSPITAL , SULLIA DK 
Address  OPD NO- 3 KAYACHIKITSA OPD, KVG AYURVEDA MEDICAL COLLEFGE AND HOSPITAL AMABATEADKA SULLIA DAKSHINA KANNADA

Dakshina Kannada
KARNATAKA
574239
India 
Phone  9964719084  
Fax    
Email  pratibhaychakrasali@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR KRISHNAPRAKASH M K  
Designation  PROFFESSOR  
Affiliation  KVG AYURVEDA MEDICAL COLLEGE AND HOSPITAL , SULLIA DK 
Address  OPD NO - 3 KAYACHIKITSA OPD, KVG AYURVEDA MEDICAL COLLEFGE AND HOSPITAL AMABATEADKA SULLIA DAKSHINA KANNADA

Dakshina Kannada
KARNATAKA
574239
India 
Phone  9482375338  
Fax    
Email  krishnaprakashmk@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR KRISHNAPRAKASH M K  
Designation  PROFFESSOR  
Affiliation  KVG AYURVEDA MEDICAL COLLEGE AND HOSPITAL , SULLIA DK 
Address  OPD NO - 3 KAYACHIKITSA OPD, KVG AYURVEDA MEDICAL COLLEFGE AND HOSPITAL AMABATEADKA SULLIA DAKSHINA KANNADA

Dakshina Kannada
KARNATAKA
574239
India 
Phone  9482375338  
Fax    
Email  krishnaprakashmk@gmail.com  
 
Source of Monetary or Material Support  
KVG AYURVEDA MEDICAL COLLEGE AND HOSPITAL AMATEADKA SULLIA DAKSHINA KANNADA KARNATAKA 574239 
 
Primary Sponsor  
Name  DR PRATIBHA  
Address  KVG AYURVEDA MEDICAL COLLEGE AND HOSPITAL  
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
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 PRATIBHA Y CHAKRASALI   KVG AYURVEDA HOSPITAL SULLIA   OPD NO - 3 KAYACHIKITSA OPD, KVG AYURVEDA MEDICAL COLLEFGE AND HOSPITAL, AMABATEADKA , SULLIA DAKSHINA KANNADA
Dakshina Kannada
KARNATAKA 
9964719084

pratibhaychakrasali@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
EHICS COMMITEE KVG AYURVEDA MEDICAL COLLEGE AND HOSPITAL SULLIA DK   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E114||Type 2 diabetes mellitus with neurological complications. Ayurveda Condition: PRAMEHA-UPADRAVAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-STHANIKA ABHYANGA (Procedure Reference: CHARAKA , Procedure details: STHANIKA ABHYANAGA FOR 14 DAYS )
(1) Medicine Name: DATTURA TAILA , Reference: YOGARATNAKARA , Route: Topical, Dosage Form: Taila, Dose: 50(ml), Frequency: od, Duration: 14 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  SUPTATA OF PRAMEHA ONLY  
 
ExclusionCriteria 
Details  PREGNANT AND LACTATING WOMEN  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
EFFECT OF DATTURA TAILA ABHYANGA IN SUPTATA WSR DIABETIC NEUROPATHY ACCORDING CHRONICITY AND SEVERITY
ASSESSED THROUGH TCNS SCALE AND STOCKING GLOVE PATTERN OF POLYNEUROPATHY 
1 ST DAY OF THE TREATMENT
14 TH DAY OF TREATMENT
21ST DAY OF TRETMENT  
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL  
 
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   Phase 3 
Date of First Enrollment (India)   10/07/2025 
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 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  
Suptata disease mentioned as one among the 80 Vatajananatmaja Vyadhi by Charaka, Vriddha Vagbhata, Sharangadhara and Kashyapa under different synonyms like Padasuptata, Suptapadata, Prasupti, Padasupti respectively, but details are not available. Bhavaprakasha explains with more details as Twakshunyata Rasaratnasamuchhaya explained as Sparshavata", but symptomatologies of Sparshavata are not exactly similar to that of Suptata. Here we are considering the symptomatology of Bhavapraksha only.

In classics we get Suptata as lakshana in Purvarupa’, Rupa Avastha and persist till Upadrava Avastha of Prameha disease. Charaka considered Upadrava as a disease where it is treated accordingly.

There is a higher prevalence of Diabetes in India (4.3%). Peripheral Neuropathy has become the most prevalent complication of diabetes over a time, at least 50% of individuals with diabetes develop neuropathy, and it has become difficulty and challenging for the physicians and patients due to its longstanding symptom, while the chronic condition disturbs the patient’s routine activities and lasts for years or become lifelong.

Twakgatavata as well as Raktagatavata are the samprapti (in brief) for Suptata. So, in Twakgatavata and Raktagatavata, Abhyanga is considered as one of the treatment 12. So we are selecting Abhyanga for the present study.

Dattura is one of the main ingredients in Vishagarbha Taila", Mahavishagarbha Taila and Vishatinduka Taila" which are indicated in Suptata with other types of Vatavyadhi. Rasakamadhenu mentioned Vishani Marutaghnani ie Visha Dravya act more effectively against Vata. So, to know the individual effect of Dattura, we considered Dattura for this Taila preparation for Abhyanga.

The above said drug is non-controversial, cost effective and easily available and Abhyanga which is easy to perform hence Dattura taila Abhyanga has been selected for the present study. As the disease selected is less explored, becoming more common and it demands more research works to be done on it and we find very minimal proven drugs and therapies in this condition, if this found effective it will be benefit for society. So, here is an attempt to know the effect of Dattura taila Abhyanga in Suptata.
 
Close