CLINICAL STUDY ON NISHOTHAMADI GHANA VATIAND BRUHAT DANTAPALA TAILA IN THE MANAGEMENT OF PSORIASIS

Phase 2

Active, not recruiting

• Conditions: ekakushta (psoriasis)

• Registration Number: CTRI/2017/08/009495
• Lead Sponsor: Shri Dharmasthala manjunatheswara college of ayurveda and hospitalhassan

Brief Summary

SUMMARY

CLINICAL STUDY ON EFFECTIVENESS OF NISHOTHAMADI GHANA VATI AND BRUHAT DANTAPALA TAILA IN THE MANAGEMENT OF EKA KUSTHA  (PSORIASIS)



Socio-psychological impacts, limitations of modern medicine and recurrence make psoriasis a burning problem among the skin diseases. It is universal in occurrence and the incidence rate is 1-3% of the population worldwide.  In India overall incidence of Psoriasis is 1.02%. Traditional practitioners of Kerala have been using a combination of Nishothamadi Kashaya and Bruhat Dantapala Taila in the management of Eka Kustha without opting for sodhana procedures.



Eka Kustha is one among kshudra kusthas, with a predominance of Vata&Kapha. This is an effort to document systematically and validate the effect of this combination in managing Eka kustha. Instead of Nishothamadi kashaya, Nishothamadi Ghanavati which is the concentrated form of kashaya (3) is selected because of its easy mode of administration as well as  increased shelf life.



The current study will be an open labeled single arm exploratory clinical trial with pre and post test design in Eka kustha(psoriasis) conducted in SDM Ayurveda hospital, Hassan.  Total Sample size - 30 patients

All the patients who fit in inclusion criteria will be given with



A) Nishothamadi Ghana vati internally - Ghanavati will be given in dosage of 4 tablets thrice daily(each 500 mg) with anupana of luke warm water for 30 days.



B) Bruhat dantapala taila externally – Taila will be applied on the lesion twice daily after bath for 30 days.



Follow up during treatment will be done on15 th and 30 th day during treatment and 15 th day after treatment to know whether the relief provided by the drugs is sustained.  Collected data will be tabulated and analysed using SPSS (Statistical package for social sciences) version 20 and using appropriate statistical tests.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-22
• Last Update Posted: 2017-06-22

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients with the lakshanas of Eka Kustha as explained in classical texts.
• Patients of either gender, between the age of 16 to 60 years .
• Patients who are ready to sign informed consent form.

Exclusion Criteria

• Psoriasis with extracutaneous manifestations like psoriatic arthritis will be excluded.
• Diagnosed Patients of uncontrolled Diabetes mellitus, tuberculosis will be excluded.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
OBJECTIVE CRITERIA	SUBJECTIVE CRITERIA |  Aswedana(anhydrosis) | 30 DAYS | OBJECTIVE CRITERIA |  Mahavastum (area of involvement is vast) |  Matsyashakalopam (Fish like scale) |  Erythema |  Induration |  Desquamation |  Positive Auspitz Sign |  Positive Candle Grease Test |  Koebner’s Phenomenon. | 30 DAYS
 Mahavastum (area of involvement is vast)	SUBJECTIVE CRITERIA |  Aswedana(anhydrosis) | 30 DAYS | OBJECTIVE CRITERIA |  Mahavastum (area of involvement is vast) |  Matsyashakalopam (Fish like scale) |  Erythema |  Induration |  Desquamation |  Positive Auspitz Sign |  Positive Candle Grease Test |  Koebner’s Phenomenon. | 30 DAYS
 Matsyashakalopam (Fish like scale)	SUBJECTIVE CRITERIA |  Aswedana(anhydrosis) | 30 DAYS | OBJECTIVE CRITERIA |  Mahavastum (area of involvement is vast) |  Matsyashakalopam (Fish like scale) |  Erythema |  Induration |  Desquamation |  Positive Auspitz Sign |  Positive Candle Grease Test |  Koebner’s Phenomenon. | 30 DAYS
 Desquamation	SUBJECTIVE CRITERIA |  Aswedana(anhydrosis) | 30 DAYS | OBJECTIVE CRITERIA |  Mahavastum (area of involvement is vast) |  Matsyashakalopam (Fish like scale) |  Erythema |  Induration |  Desquamation |  Positive Auspitz Sign |  Positive Candle Grease Test |  Koebner’s Phenomenon. | 30 DAYS
 Erythema	SUBJECTIVE CRITERIA |  Aswedana(anhydrosis) | 30 DAYS | OBJECTIVE CRITERIA |  Mahavastum (area of involvement is vast) |  Matsyashakalopam (Fish like scale) |  Erythema |  Induration |  Desquamation |  Positive Auspitz Sign |  Positive Candle Grease Test |  Koebner’s Phenomenon. | 30 DAYS
 Induration	SUBJECTIVE CRITERIA |  Aswedana(anhydrosis) | 30 DAYS | OBJECTIVE CRITERIA |  Mahavastum (area of involvement is vast) |  Matsyashakalopam (Fish like scale) |  Erythema |  Induration |  Desquamation |  Positive Auspitz Sign |  Positive Candle Grease Test |  Koebner’s Phenomenon. | 30 DAYS
 Positive Candle Grease Test	SUBJECTIVE CRITERIA |  Aswedana(anhydrosis) | 30 DAYS | OBJECTIVE CRITERIA |  Mahavastum (area of involvement is vast) |  Matsyashakalopam (Fish like scale) |  Erythema |  Induration |  Desquamation |  Positive Auspitz Sign |  Positive Candle Grease Test |  Koebner’s Phenomenon. | 30 DAYS
 Koebner’s Phenomenon.	SUBJECTIVE CRITERIA |  Aswedana(anhydrosis) | 30 DAYS | OBJECTIVE CRITERIA |  Mahavastum (area of involvement is vast) |  Matsyashakalopam (Fish like scale) |  Erythema |  Induration |  Desquamation |  Positive Auspitz Sign |  Positive Candle Grease Test |  Koebner’s Phenomenon. | 30 DAYS
30 DAYS	SUBJECTIVE CRITERIA |  Aswedana(anhydrosis) | 30 DAYS | OBJECTIVE CRITERIA |  Mahavastum (area of involvement is vast) |  Matsyashakalopam (Fish like scale) |  Erythema |  Induration |  Desquamation |  Positive Auspitz Sign |  Positive Candle Grease Test |  Koebner’s Phenomenon. | 30 DAYS
 Positive Auspitz Sign	SUBJECTIVE CRITERIA |  Aswedana(anhydrosis) | 30 DAYS | OBJECTIVE CRITERIA |  Mahavastum (area of involvement is vast) |  Matsyashakalopam (Fish like scale) |  Erythema |  Induration |  Desquamation |  Positive Auspitz Sign |  Positive Candle Grease Test |  Koebner’s Phenomenon. | 30 DAYS
SUBJECTIVE CRITERIA	SUBJECTIVE CRITERIA |  Aswedana(anhydrosis) | 30 DAYS | OBJECTIVE CRITERIA |  Mahavastum (area of involvement is vast) |  Matsyashakalopam (Fish like scale) |  Erythema |  Induration |  Desquamation |  Positive Auspitz Sign |  Positive Candle Grease Test |  Koebner’s Phenomenon. | 30 DAYS
 Aswedana(anhydrosis)	SUBJECTIVE CRITERIA |  Aswedana(anhydrosis) | 30 DAYS | OBJECTIVE CRITERIA |  Mahavastum (area of involvement is vast) |  Matsyashakalopam (Fish like scale) |  Erythema |  Induration |  Desquamation |  Positive Auspitz Sign |  Positive Candle Grease Test |  Koebner’s Phenomenon. | 30 DAYS

Trial Locations

Locations (1)

Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital,; 🇮🇳 Hassan, KARNATAKA, India

Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital,

🇮🇳Hassan, KARNATAKA, India

Dr Yadu narayanan Mooss

Principal investigator

9895077090

yadu.mooss@gmail.com