| 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
|
|
|
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
|
|
|
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | 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. |