| CTRI Number |
CTRI/2024/04/065439 [Registered on: 09/04/2024] Trial Registered Prospectively |
| Last Modified On: |
09/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Radiation Therapy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study of Medicated Oil and Phototherapy in Management of Skin Disease (Vitiligo) Shvitra. |
|
Scientific Title of Study
|
A Comparative Clinical Trial To Assess the Effect of Kushthrakshas tail and Phototherapy in Shvitra with special reference to Bhrajak Pitta |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sonali Rawat |
| Designation |
M D Scholar |
| Affiliation |
National Institute of Ayurveda |
| Address |
Department of kriya Sharir Room No 218 National Institute of Ayurveda
Madhav Vilas Palace Jorawar Singh Gate Amer Road
JAIPUR 302002 RAJASTHANÂ INDIA
Jaipur
RAJASTHAN
302002
India |
| Phone |
7055962744 |
| Fax |
|
| Email |
sonali.rawat.rs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Chhaju Ram Yadav |
| Designation |
Professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
Department of Kriya Sharir Room no 218 National Institute of Ayurveda
Madhav Vilas Palace Jorawar Singh Gate Amer Road
JAIPUR 302002 RAJASTHANÂ INDIA
Jaipur
RAJASTHAN
302002
India |
| Phone |
9460866101 |
| Fax |
|
| Email |
dr.yadavcr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rashmi Prakash Gurao |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
Department of Kriya Sharir Room no 218 National Institute of Ayurveda
Madhav Vilas Palace Jorawar Singh Gate Amer Road
JAIPUR 302002 RAJASTHANÂ INDIA
Jaipur
RAJASTHAN
302002
India |
| Phone |
9284142677 |
| Fax |
|
| Email |
drrashmigurao@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda Deemed to be university Jorawar Singh Gate Jaipur 302002 |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda |
| Address |
Madhav Vilas Palace Jorawar Singh Gate Amer Road
JAIPUR 302002 RAJASTHANÂ INDIA |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NOT APPLICABLE |
NOT APPLICABLE |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sonali Rawat |
National Institute of Ayurveda Jaipur |
Department of Kriya Sharir OPD No 3 National
Institute of Ayurveda
Hospital Jaipur
Rajasthan
Jaipur
RAJASTHAN |
7055962744
sonali.rawat.rs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L80||Vitiligo. Ayurveda Condition: SVITRAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kustharakshas tail, Reference: Bharat Bhaisagya Ratnakar, Route: Topical, Dosage Form: Taila, Dose: 30(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: Taila should be given as per patient disease condition | | 2 | Comparator Arm (Non Ayurveda) | | - | Phototherapy | The affected part will be treated with narrowband UVB monotherapy with a wavelength
of 311 nanometers for about 20 minutes
The patient will be advised to refrain from extreme sun exposure & use of cosmetics
2 sessions per week over a period of 12 weeks will be conducted
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Subjects of either sex aged between 18 60 years
2 Subjects with diagnosed case of Shvitra |
|
| ExclusionCriteria |
| Details |
1 Kco chronic systemic diseases Sexually Transmitted Diseases uncontrolled Diabetes
Mellitus Hypertension Blood Disorders or any organ failure
2 Contraindications of Phototherapy like Kco skin allergies photosensitive disorder
pregnancy breastfeeding women SLE etc
3 Taking any other medication for the same illness
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
PRIMARY OUTCOME
Change in the grade of VASI Vitiligo Area Severity Index score of Vitiligo
|
90 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in classical signs and symptoms like vaivarnya,suptata,atti chirouthitha,
sfutata etc. |
15 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
10/10/2024 |
| Date of Study Completion (India) |
03/10/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
2 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
All the demographic and clinical data is presented and analysed in this section. Tabulated and Graphs of all observed data regarding of diseases, subjective parameters inserted. All the observations pertaining to the clinical study have been recorded and mentioned here Results of various intragroup and intergroup observations on criteria of assessment with respect to different statistical tests have been assessed, tabulated and analysed.
Based on the observation done and results obtained, a logical discussion has been carried out of demographic results, objective and subjective criteria, results, mode of action of used drugs in clinical trial.
In conclusion, this dissertation presents a comprehensive analysis of fruits based on a clinical study. While the research findings have provided valuable insights, it is important to acknowledge the limitations of the study. Further investigations are warranted to delve deeper into specific aspects that require more exploration. The broader scope for future studies should focus on expanding the sample size, considering longer-term effects, and incorporating diverse methodologies to enhance our understanding of fruits and their impact on health. Overall, this dissertation serves as a foundation for future research in this area, shedding light on the significance of fruits in promoting well-being and offering a promising avenue for continued scientific inquiry. |