| CTRI Number |
CTRI/2024/03/064854 [Registered on: 27/03/2024] Trial Registered Prospectively |
| Last Modified On: |
23/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
Ayurvedic drug for Vyanga. |
|
Scientific Title of Study
|
"PHARMACOGNOSTICAL AND COMPARATIVE CLINICAL STUDY OF KADAMBA (Anthocephalus cadamba (Roxb)Miq)STEM BARK AND LEAF IN VYANGA". |
| 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 ARABATI KAVYA RASHMIKA |
| Designation |
PG SCHOLAR |
| Affiliation |
DR BRKR GOVT AYURVEDIC MEDICAL COLLEGE ERRAGADDA HYDERABAD TELANGANA |
| Address |
OPD No 4 Department of Dravyaguna DR BRKR Govt Ayurvedic Medical college and hospital Erragadda Hyderabad
Hyderabad
TELANGANA
500038
India |
| Phone |
9949013243 |
| Fax |
|
| Email |
kavyaarabati04@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr GATTU SWARUPA RANI |
| Designation |
PROFESSOR |
| Affiliation |
DR BRKR GOVT AYURVEDIC MEDICAL COLLEGE |
| Address |
Department of Dravyaguna Dr BRKR Govt Ayurvedic medical college and Hospital Erragadda Hyderabad
Hyderabad
TELANGANA
500038
India |
| Phone |
9441905338 |
| Fax |
|
| Email |
gattusr135@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr GATTU SWARUPA RANI |
| Designation |
PROFESSOR |
| Affiliation |
DR BRKR GOVT AYURVEDIC MEDICAL COLLEGE |
| Address |
Department of Dravyaguna
Dr BRKR Government Ayurvedic Medical college and Hospital Erragadda Hyderabad
Hyderabad
TELANGANA
500038
India |
| Phone |
9441905338 |
| Fax |
|
| Email |
gattusr135@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr BRKR Government Ayurvedic Medical College and Hospital Erragadda Hyderabad |
|
|
Primary Sponsor
|
| Name |
DR ARABATI KAVYA RASHMIKA |
| Address |
Department of Dravyaguna
DR BRKR Government Ayurvedic Medical College Erragadda Hyderabad 500038 |
| Type of Sponsor |
Government medical college |
|
|
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 ARABATI KAVYA RASHMIKA |
DR BRKR GOVT AYURVEDIC MEDICAL COLLEGE AND HOSPITAL |
OPD 4, Department of Dravyaguna
DR BRKR Govt Ayurvedic Medical college and hospital Erragadda Hyderabad 500038
Hyderabad
TELANGANA |
9949013243
kavyaarabati04@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethical Committee of Dr B.R.K.R Government Ayurvedic College Hyderabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L814||Other melanin hyperpigmentation. Ayurveda Condition: VYANGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kadamba Leaf, Reference: Susrutha samhitha, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: water), Additional Information: In susrutha samhitha sutrasthana 38th chapter lodhradi gana kadamba is used as varnya.(2) Medicine Name: Kadamba Leaf , Reference: Susrutha samhitha, Route: Topical, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: water), Additional Information: In susrutha samhitha sutrasthana 38th chapter lodhradi gana kadamba is used as varnya. | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kadamba stembark, Reference: susrutha samhitha, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: water), Additional Information: In susrutha samhitha sutrasthana 38th chapter lodhradi gana Kadamba is used as varnya(2) Medicine Name: Kadmaba stembark, Reference: Susrutha samhitha, Route: Topical, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: water), Additional Information: In susrutha samhitha sutrasthana 38th chapter lodhradi gana Kadamba is used as varnya |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with signs and symptoms of vyanga.
2.Shyava varna yukta, niruja mandalas, parushatva present on face.
3.Skin patch test for assessment of sensitivity.
|
|
| ExclusionCriteria |
| Details |
1.Hyperpigmentation caused since birth.
2.Patients with psychosomatic disorders.
3.Pregnant women and lactating mothers.
4.patients suffering with chronic illness like Thyroid, CKD, CAD, HIV . |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To decrease the size and number of dark brown color patches on face.
2.To reduce the roughness on face. |
0, 15th day,30th day, 45th day, 60th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. To improve complexion on face. |
0,15th day,30th day,45th day,60th day. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 2 |
|
Date of First Enrollment (India)
|
04/04/2024 |
| 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="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
|
Skin diseases are one of the common manifestations in the present era as the patients experience physical, emotional and socio-economic embrassement in society due to disfigured appearance .In Ayurveda all the skin diseases are mentioned in kushta and kshudra roga causing due to imbalance of dosas affecting all the ages. vyanga is considered one among the Kshudra roga . Indulgence in incompatible food and drinks, atidrava, atisnigdha ahara, suppression of natural urges, too much exposure to heat ,excessive indulgence in physical activities, improper administration of purificatory therapies, excessive anger, grief causes vitiation of vata in combination with pitta with clinical features of painless , thin, black coloured patches ,with roughness, itching on face . In susrutha Samhita sutrastana Lodhradigana Acharya Sushruta has mentioned Kadamba (Anthocephalus cadamba(Roxb)Miq) contain varnya property. Kadamba acts as vatapitta shamaka, twak prasadaka . RESEARCH DESIGN 1.Organoleptic study, physicochemical study and phytochemical study of Kadamba (Anthocephalus cadamba(Roxb)Miq) stem bark and leaf. 2. Randomized comparative clinical study with signs and symptoms of Vyanga are taken into 2 groups. Group 1 is given Kadamba leaf powder and Group 2 Kadamba stem bark powder is given at outpatient department of Government Ayurvedic Hospital, Erragadda, Hyderabad. 3.Dose:Group 1: Internal: 3gms of leaf powder is given with water twice a day after food. External: Dose as required for external application with water twice a day. Group 2: Internal : 3gms of stem bark powder is given with water twice a day after food. External: Dose as required for external application with water twice a day. |