A clinical study to evaluate the effect Of Amruthadi Kashaya in the management of Sheethapitta

Phase 1/2

Not yet recruiting

Brief Summary: This study is a Open label Comparative Clinical trial toevaluate the efficacy of *Amruthadi kashaya* as an add on drugto *Haridrakhanda*and *Sarshapathaila.*

Subjects are allocated in to study and comparatorgroups respectively.Minimum of 30 patients diagnosed as suffering from *Sheethapitta* fulfillingthe inclusion criteria irrespective of sex & religion will be selectedfor the comparative study. A separate case sheet pro forma will be prepared& subjects will be examined.

They will be divided in to 2 equalGroups A and B, where Group A will be administered with *Amruthadikashaya* 50 ml twice daily before food along with *Haridra*khanda6gm twice daily before food. In Group B, *Haridrakhanda* alonewill be administered in the dosage of 6gm twice daily before food*Sarshapathaila* willbe given for both groups for external application

**SUBJECTIVE PARAMETER:**

***Lakshanas*****of *Sheethapitta***

- *Varati Damshta Samsthana Shotha*(Inflammation like an insect bite)

- *Kandu*(Severe itching)

- *Toda*(Excessive pain like pricking)

- *Vidaha*(Burning Sensation)

- *Sa utsanga Saraga Mandala*(Red Patches)

- *Kshanikotpattivinash*(Transient)

**Associated symptoms if any**:

- *Pipasa*(excessive thirst)

- *Jvara*(fever)

- *Chhardi*(vomiting*)*

- *Vibandha*(constipation)

- *Raktalochanata*(reddish discoloration of the eyes)

- *Dehasada*(tiredness of the body)

**OBJECTIVE PARAMETER:**

**Urticaria activity score=Itch severity score + no of hives**

Recruitment & Eligibility

Inclusion Criteria

Subjects with classical lakshana of Sheethapitta.
Subjects of either sex & religion within the age group of 18 to 60 years will be included.
Subjects who are not having angioedema.
Chronic spontaneous urticaria with duration greater than 6 weeks.
Episodic urticaria with duration greater than 6 weeks.
Subjects who are not on steroid medications.

Exclusion Criteria

Subjects suffering from serious systemic disorders like uncontrolled diabetes mellitus, SLE, Sjogrenâ€™s syndrome, autoimmune thyroid diseases, respiratory tract infection10.
Angio edema.
Acute urticaria less than 6 weeks.
Subjects who are on steroid medications.

Primary Outcome Measures

Name	Time	Method
Varati Damshta Samsthana Shotha (Inflammation like an insect bite)	1st Assessment on 1st day \| 2nd Assessment on 11th day \| 3rd Assessment on 21st day
Raktalochanata (reddish discoloration of the eyes)	1st Assessment on 1st day \| 2nd Assessment on 11th day \| 3rd Assessment on 21st day
Kandu (Severe itching)	1st Assessment on 1st day \| 2nd Assessment on 11th day \| 3rd Assessment on 21st day
Toda (Excessive pain like pricking)	1st Assessment on 1st day \| 2nd Assessment on 11th day \| 3rd Assessment on 21st day
Kshanikotpattivinash(Transient)	1st Assessment on 1st day \| 2nd Assessment on 11th day \| 3rd Assessment on 21st day
Vibandha (constipation)	1st Assessment on 1st day \| 2nd Assessment on 11th day \| 3rd Assessment on 21st day
Dehasada (tiredness of the body)	1st Assessment on 1st day \| 2nd Assessment on 11th day \| 3rd Assessment on 21st day
Vidaha (Burning Sensation)	1st Assessment on 1st day \| 2nd Assessment on 11th day \| 3rd Assessment on 21st day
Sa utsanga Saraga Mandala (Red Patches)	1st Assessment on 1st day \| 2nd Assessment on 11th day \| 3rd Assessment on 21st day
Pipasa (excessive thirst)	1st Assessment on 1st day \| 2nd Assessment on 11th day \| 3rd Assessment on 21st day
Jvara (fever)	1st Assessment on 1st day \| 2nd Assessment on 11th day \| 3rd Assessment on 21st day
Chhardi (vomiting)	1st Assessment on 1st day \| 2nd Assessment on 11th day \| 3rd Assessment on 21st day

Secondary Outcome Measures

Name	Time	Method
Urticaria Activity Score	1st Assessment on 1st day

Locations (1): Sri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Bengaluru
🇮🇳
Bangalore, KARNATAKA, India
Sri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Bengaluru
🇮🇳Bangalore, KARNATAKA, India
Dr Chithra Ramachandran
Principal investigator
8943560076
herechithra@gmail.com