DHATRYADI KWATHA ORALLY AND FALGU PATRA SWARASA APPLICATION WITH AND WITHOUT VIRECHANA IN SHWITRA(VITILIGO)

Phase 1/2

Completed

Conditions: Vitiligo,

Registration Number: CTRI/2016/04/006785

Lead Sponsor: IPGT and RA GAU JAMNAGAR GUJARAT

Brief Summary: 1.     *Shwitra* characterizedby white patches which effectively resembles and represents Vitiligo accordingto modern science.

2.     Most of the patients of*Shwitra* were more concerned about *Shweta Mandala* (hypo pigmented or white coloured patches) insteadof any other symptoms of *Shwitra* and visit hospital for same.

3.     *Viruddha Ahara*(incompatible diet) like milk with salt, milk with sour foods, excess taking offermented foods were observed in most of patients of *Shwitra*.

4.     *Virechana*, *Dhatryadi Kwatha* and External application of *Phalgu*-*patra* *swarasa* (Group A) therapy showed betterresults in cardinal symptoms like colour, number, area and size of patches than*Dhatryadi Kwatha* and External application of *Phalgu*-*patra* *swarasa* (Group B) therapy.

5.     Group B showed better effect on *Mandalotpatti* and *Rukshata* like symptoms.

6.     Group A presented better repigmentationresponse on face, neck, dorsa of hands, elbows and ankles and didnâ€™t respond ondistal extremities and on *Sansrishta* (mixed one anotherpatches).

7.     *Virechana* group showed betterresult in VASI, VETF and VETI score as compare to *Shamana* group.

8.     Group A exhibited better percentage fractionthan Group B on Quality of life parameters i.e. DLQI, VitiQoL and VIS-22.

9.     Results of Group B indicated that effectiveinhibition of the inflammatory response alone might not be sufficient to inducespontaneous repigmentation in *Shwitra* (Vitiligo).

10. Overall60% patients showed moderate improvement, 33.33% patients showed markedimprovement and 6.67% showed mild improvement in Group A. Overall 66.67%patients showed mild improvement while 33.33% patients showed moderateimprovement in Group B.

11. Therapeutically, both thegroups (Group A- *Virechana*, *Dhatryadi Kwatha* and External application) and Group B- *Dhatryadi Kwatha* and External application) providedconsiderable symptomatic relief. However, Group A (*Virechana* group) was found to berelatively more effective in the management of majority of the symptoms and onquality of life.

Hence, the null hypothesis is rejected andalternative hypothesis is accepted i.e. â€œ*Dhatryadi Kwatha* and external application of *Phalgu-patra swarasa* are more effective along with *Virechana* in the management of *Shwitra* (Vitiligo)â€.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 30

Inclusion Criteria

1.Patients having sign and symptoms of Shwitra (Vitiligo).
Patients indicated for Virechana as per Ayurvedic classics.
If the patients to withdrawn ongoing medications like systemic corticosteroids, systemic or local photosensitizers or drugs scientifically proven to cause hyperpigmentation on local application or systemic administration will be included.
Washout period after quitting will be for 7 days.

Exclusion Criteria

1.Patients having chronic condition, more than 10 years 2.Patients contraindicated for Virechana as per Ayurvedic classics.
3.Patients having all other de-pigmentory disorders.
4.Patients having serious cardiac, renal, hepatic diseases.
5.Patients having major illness like IDDM, NIDDM which are poorly controlled and any other systemic diseases.
6.Patches due to burning, chemical explosion etc.
7.Located at region of Guhya(Genital region), Panitala(Foot soles and Hand soles), Oshtha (Lips), Aekanga, Sarvanga(whole body).
8.Patches with Raktaroma & sansakta.
9.Patients with known drug hypersensitivity, photosensitivity, 10.Pregnant and lactating women.
11.Patients with ongoing medications like systemic corticosteroids, systemic or local photosensitizers or drugs scientifically proven to cause hyperpigmentation on local application or systemic administration.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ASSESSMENT WILL BE DONE ON THE SPECIALLY DESIGNED PROFORMA OR ASSESSING SIGN AND SYMPTOMS IN SCORING PATTERN	2 MONTHS

Secondary Outcome Measures

Name	Time	Method
ASSESSMENT WILL BE DONE ON THE SPECIALLY DESIGNED PROFORMA OR ASSESSING SIGN AND SYMPTOMS IN SCORING PATTERN	2 MONTHS

Trial Locations

Locations (1): IPGT & RA GUJARAT AYURVED UNIVERSITY JAMNAGAR GUJARAT
🇮🇳
Jamnagar, GUJARAT, India
IPGT & RA GUJARAT AYURVED UNIVERSITY JAMNAGAR GUJARAT
🇮🇳Jamnagar, GUJARAT, India
DR RAJDIP RAO
Principal investigator
8460132141
rajdip.rao@gmail.com