| CTRI Number |
CTRI/2020/01/022941 [Registered on: 27/01/2020] Trial Registered Prospectively |
| Last Modified On: |
09/01/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Homeopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Role of Ayurveda and Homeopathy in the management of Skin tags |
|
Scientific Title of Study
|
A Randomized Clinical Study To Evaluate The Efficacy Of Integrated Ayurvedic And Homoeopathic Therapy In The Treatment Of Warts |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajashekhar V Sanapeti |
| Designation |
Associate Professor |
| Affiliation |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya |
| Address |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9611442881 |
| Fax |
|
| Email |
rajashekharpk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajashekhar V Sanapeti |
| Designation |
Associate Professor |
| Affiliation |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya |
| Address |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi
KARNATAKA
590003
India |
| Phone |
9611442881 |
| Fax |
|
| Email |
rajashekharpk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajashekhar V Sanapeti |
| Designation |
Associate Professor |
| Affiliation |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya |
| Address |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi
KARNATAKA
590003
India |
| Phone |
9611442881 |
| Fax |
|
| Email |
rajashekharpk@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi |
|
|
Primary Sponsor
|
| Name |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya |
| Address |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi - 590003 |
| 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 |
| Dr Rajashekhar V Sanapeti |
KLE Ayurveda Hospital |
OPD no 04 and IPD of KLE Ayurveda Hospital Shahapur Belagavi - 590003
Belgaum
KARNATAKA |
9611442881
rajashekharpk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KAHERs Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Homoeopathic treatment |
Thuja occidentalis: Large, Filiform ( Pedunculated), Flat Warts, Moist, Bleeding, Brown, Rough and Painful. Left Sided and Chilly.
Nitric acid: Large, Rough, Pedunculated warts, bleeding readily on washing, moist, sticking pain. Persons who take cold easily, disposed to diarrhea.
Bramhananda Tripathi, Charaka samhita, Sutra sthana, 15th chapter, verse -105, Chaukamba Surabharati Prakashana; Varanasi; 2012
Bramhananda Tripathi, Charaka samhita, Sutra sthana, 25th chapter, verse -105, Chaukamba Surabharati Prakashana; Varanasi; 2012
Causticum: Large or small, rough, pedunculated warts, bleeding easily, moist, all over the body, on eyelids, face, on the nose. Right sided and chilly. Sympathetic and sad.
Dulcamara: Fleshy, Large, Smooth warts, on the face or back of hands and fingers. Complaints from suppressed sweat, eruptions and menstruation. Chilly.
Ruta graveolens: Warts with sore pains, flat, smooth, on palms of hands. Restless.
Natrum muriaticum: Warts on palms of hands. Weepy and irritable, consolation aggravation. Left sided and hot. Better without regular meals.
Calcarea ostrearum (carbonicum): Isolated, small, bleeding, red ,hard and rough warts on arms, fingers and face (left) cheek. Sweating on single parts, especially head. Chilly. Better when constipated.
1Antimonium crudum: Warts around the nails, rough, complaints aggravated by cold bath, heat of sun. Thirstless.
1Sulphur: Hard, small, dry warts with burning and itching, on left forearm, eyelids and around the eyes, ring finger and soles. Aggravated by washing, warmth.
Natrum sulphuricum: Warts around eyes, scalp, face, chest, anus., moist. Caused by long exposure to dampness.
|
| Intervention |
Shodhana chikitsa followed by Homoeopathic treatment |
Virechana karma Trivrit lehya 10 – 20 gms will be advised as Muhur muhur Virechana (2-3 times in a period of week)
OR
Snehapana with Pancha tiktaka grita
(till the attainment of Samyak snigdha lakshanas appox 3-7 days)
Sarvanaga Parisheka with Dashamoola + Amrita kashaya
(Sarvanga abhyanga optional based on fittness) for 2 – 3 days
Virechana karma with Trivrit lehya (20-50 gms w.r.t Koshta)
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient presenting with the Signs of warts
Patients with warts of less than 4 years duration
Age between 19 – 60 years
Either sex
Fit for Shodhana treatment
|
|
| ExclusionCriteria |
| Details |
Patients with ano- genital warts and epidermodysplasia verruciformis will be excluded
Pregnant and lactating women will be excluded.
Patients with HIV or on immunosuppressive therapy will be excluded
Patients with warts of more than 4 years duration will be excluded.
Patients not fit for shodhana chikitsa will be excluded.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Integrated Protocol will be beneficial by reducing the external growth size without surgical intervention |
30th, 60th, 90th, 120th, 150th, 180th, 210th, 240th, 270th, 300th, 330th, 360th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
02/03/2020 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Warts being
common manifestation throughout the world,
has been estimated that 2-30% of school age children and young adults.
The common sites affected are hands, feet, face and genitalia. Transmission is
by simple contact, often at sites with small skin breaks, abrasions or other
trauma. The patients with warts seek treatment due to the unsightly appearance which
effects the quality of life, fear of spread or enlargement or discomfort
from pressure1. Multiple treatments are available for warts in
modern medicine, but no single treatment is consistently highly effective2. Panchakarma (Shodhana -
biopurificatory) treatments will
eliminate the morbod factors responsible for the genesis of disease3 and are proved effective
in the management of warts. Virechanana karma (Theraupetic Purgation) is Shodhana procedure that eliminate morbid Piita
dosha4 and thereby removing the
toxins out of the body.
Though homoeopathy is
effective in treatment of warts, the need for this study is to see whether we
can relieve the patient of his complaints faster with integrated approach,
namely shodhan chikitsa of ayurveda and homoeopathic medication , as both these
systems treat the patient as a whole. |