| CTRI Number |
CTRI/2020/01/022844 [Registered on: 17/01/2020] Trial Registered Prospectively |
| Last Modified On: |
03/01/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
EFFECT OF AYURVEDIC MANAGEMENT IN THE MANAGEMENT OF PSORIASIS |
|
Scientific Title of Study
|
CLINICAL EVALUATION OF PANCHATIKTA GHRITA & NALPAMARADI TAILA IN THE MANAGEMENT OF PSORIASIS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrAminHetalben |
| Designation |
Research Officer (Ay.) |
| Affiliation |
Central Council for Research in Ayurvedic Sciences (C.C.R.A.S.) |
| Address |
Regional Ayurveda Research Institute for Skin disorders Ahmedabad
Jawahar Lal Nehru BhartiyaChikitsaEvam Homoeopathy AnusandhanBhawan
61-65 Institutional Area,Opposite D-Block Janakpuri New Delhi 110058
Ahmadabad
GUJARAT
380004
India |
| Phone |
079-29708072 |
| Fax |
|
| Email |
drhetal.amin@gov.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DrAminHetalben |
| Designation |
Research Officer (Ay.) |
| Affiliation |
Central Council for Research in Ayurvedic Sciences (C.C.R.A.S.) |
| Address |
Regional Ayurveda Research Institute for Skin disorders Ahmedabad
Jawahar Lal Nehru BhartiyaChikitsaEvam Homoeopathy AnusandhanBhawan
61-65 Institutional Area,Opposite D-Block Janakpuri New Delhi 110058
GUJARAT
380004
India |
| Phone |
079-29708072 |
| Fax |
|
| Email |
drhetal.amin@gov.in |
|
Details of Contact Person
Public Query
|
| Name |
DrAminHetalben |
| Designation |
Research Officer (Ay.) |
| Affiliation |
Central Council for Research in Ayurvedic Sciences (C.C.R.A.S.) |
| Address |
Regional Ayurveda Research Institute for Skin disorders Ahmedabad
Jawahar Lal Nehru BhartiyaChikitsaEvam Homoeopathy AnusandhanBhawan
61-65 Institutional Area,Opposite D-Block Janakpuri New Delhi 110058
GUJARAT
380004
India |
| Phone |
079-29708072 |
| Fax |
|
| Email |
drhetal.amin@gov.in |
|
|
Source of Monetary or Material Support
|
| Regional Ayurveda Research Institute for Skin Disorders, Ahmedabad and Regional Ayurveda Research Institute for Skin Disorders, Vijaywada |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Ayurvedic Sciences CCRAS |
| Address |
Jawahar Lal Nehru BhartiyaChikitsaEvam Homoeopathy AnusandhanBhawan
61-65 Institutional Area,Opposite D Block Janakpuri New Delhi 110058
|
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrAnumol K |
Regional Ayurveda Research Institute for Skin disorders Vijaywada |
Out patient Department
|
0866-2402535
dranumolk@gmail.com |
| DrHetalAmin |
Regional Ayurveda Research Institute for Skin disorders, Ahmedabad |
Out patient Department
Ahmadabad
GUJARAT |
9924194660
drhetal.amin@gov.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| RegionalAyurvedaResearch Institute for Skin disorders Ahmedabad |
Approved |
| RegionalAyurvedaResearch Institute for Skin disorders, Vijaywada |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L401||Generalized pustular psoriasis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NalpamaradiTaila (Ref: Sahasrayoga AFI - I, API Part II, Vol - III)
|
Dose: 20ml BD
Dosage form : Oil
Route of Administration : External application
Time of Administration : Twice a day
Duration of therapy : 12 weeks
|
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
PanchatiktaGhrita (Ref: BhaishajyaRatnavali AFI - I, API Part - II, Vol - I) |
Dose : 6 gm BD Dosage form : Ghrita Route of Administration : Oral Time of Administration : Twice a day before food Anupana : Luke warm water Duration of therapy : 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either sex with age between 18 and 60 years.
2. Known cases of psoriasis, without psoriatic arthropathy, Exhibiting psoriatic triad –
a. Bright pink or red lesions with pronounced edges, covered with silvery white scales, the scales can be easily separated from the lesion.
b. Under the scales there appears a pinkish moist tender skin.
c. With the scraping of the moist skin there appear tiny blood droplets (Auspitz’s sign)
3. Patients suffering from psoriasis with less than 50 % of the body surface involvement.
4. Disease duration between 3 months to 5 years.
5. V.D.R.L./ HIV/Hepatitis negative.
6. Positive histopathological finding.(Skin-biopsy)
7. Willing to participate in the study
|
|
| ExclusionCriteria |
| Details |
1. Generalized skin lesions, Herpes simplex, Herpes zoster, Scabies, Acne, Urticaria, and Immunological medicated skin diseases like Pempigus vulgaris, Dermatitis,herpetiformis, Guttate, Pustular, Lupus erythematous, Psoriatic arthropathy etc.
2. Patients with poorly controlled Hypertension (Blood pressure more than 160/100mm of Hg).
3. Pregnant or lactating women.
4. Patient with uncontrolled Diabetes Mellitus (Blood sugar fasting more than 250 mg/dl).
5. Patient suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, cardiovascular disease Tuberculosis, Psycho - Neuro-endocrinal disorders, etc.).
6. Patients on medication with corticosteroids, phototherapy, biologics,antidepressants any other drugs that may have an influence on the outcome of the study.
7. Patients with concurrent serious Hepatic Dysfunction (defined as AST and/or ALT >3 times of the upper normal limit) or Renal Dysfunction (defined as S. creatinine > 1.4 mg/dl) oruncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or AIDS or STD or other concurrent severe disease.
8. Alcoholics and/or drug abusers.
9. H/o hypersensitivity to the trial drug or any of its ingredients.
10. Patients who have completed participation in any other clinical trial during the past six months.
11. Any other condition which the Investigator thinks may jeopardize the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in Psoriasis Area and Severity Index(PASI) score |
84 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in the clinical Sign & symptoms ofPsoriasis
Change in Dermatology life Quality Index (DLQI) Questionnaire
|
84 day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
03/02/2020 |
| 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
|
Final Results of the trial will be published by CCRAS, new Delhi |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Psoriasis is a chronic, noncommunicable, painful, disfiguring and disabling disease for which there is no cure and with great negative impact on patients’ quality of life (QoL). It can occur at any age, and is most common in the age group 50–69 . The reported prevalence of psoriasis in countries ranges between 0.09% (2) and 11.4% , making psoriasis a serious global problem. The etiology of psoriasis remains unclear, although there is evidence for genetic predisposition . The role of the immune system in psoriasis causation is also a major topic of research. Although there is a suggestion that psoriasis could be an autoimmune disease, no autoantigen that could be responsible has been defined yet. Psoriasis can also be provoked by external and internal triggers, including mild trauma, sunburn, infections, systemic drugs and stress. Psoriasis causes great physical, emotional and social burden .QoL, in general, is often significantly impaired . Disfiguration, disability and marked loss of productivity are common challenges for people with psoriasis. Treatment of psoriasis is still based on controlling the symptoms. Psoriasis is categorized in Ayurveda as a vata-kapha disease. There are many classical Ayurveda formulations indicated for skin diseases and Psoriasis in particular . The Ayurvedic Pharmacopeia of India has laid standards of Ayurvedic formulations appeared in Ayurvedic Formulary of India. Oral administration of PanchatiktaGhrita and local application of NalpamaradiTailaare the formulations commonly used by Ayurvedic physicians in the management of Psoriasis and the pharmacopeial standards are available for both these formulation. Considering this, the Council has undertaken the validation of these two formulations to generate the evidence of their clinical efficacy and safety in the management of Psoriasis under validation of classical ayurvedic formulations programme under Annual action Plan 2017-18. |