| CTRI Number |
CTRI/2023/07/055801 [Registered on: 28/07/2023] Trial Registered Prospectively |
| Last Modified On: |
04/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to evaluate the effect Of Amruthadi Kashaya in the management of Sheethapitta |
|
Scientific Title of Study
|
Clinical Evaluation Of Amruthadi Kashaya in the management of Sheethapitta,an active controlled clinical study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chithra Ramachandran |
| Designation |
Postgraduate Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, |
| Address |
Postgraduate Scholar
Department of PG studies in Kayachikitsa
Sri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Anchepalya, Kumbalgodu post, Bengaluru
Bangalore
KARNATAKA
560074
India |
| Phone |
8943560076 |
| Fax |
|
| Email |
herechithra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Priya Bhat |
| Designation |
Associate professor |
| Affiliation |
Sri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, |
| Address |
Associate Professor
Department of PG studies in Kayachikitsa
Sri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Anchepalya, Kumbalgodu post, Bengaluru
SHRI DHARMASTHALA MANJUNATHESHWARA INSTITUTE OF AYURVEDA AND HOSPITAL, BENGALURU, KARNATAKA-560074
Bangalore
KARNATAKA
560074
India |
| Phone |
09986451162 |
| Fax |
|
| Email |
dr.priyabhat23@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chithra Ramachandran |
| Designation |
Postgraduate Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, |
| Address |
Postgraduate Scholar
Department of PG studies in Kayachikitsa
Sri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Anchepalya, Kumbalgodu post, Bengaluru
KARNATAKA
560074
India |
| Phone |
8943560076 |
| Fax |
|
| Email |
herechithra@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Anchepalya, Kumbalgodu post, Bengaluru- 560074 |
|
|
Primary Sponsor
|
| Name |
Dr Chithra Ramachandran |
| Address |
Postgraduate Scholar
Department of PG studies in Kayachikitsa
Sri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Anchepalya, Kumbalgodu post, Bengaluru- 560074
|
| Type of Sponsor |
Private medical college |
|
|
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 Chithra Ramachandran |
Sri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Bengaluru |
Department of PG studies in Kayachikitsa
Bangalore
KARNATAKA |
8943560076
herechithra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Anchepalya, Bengaluru,Karnataka – 560074 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L501||Idiopathic urticaria. Ayurveda Condition: SITAPITTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Haridrakhanda, Reference: Bhaishajya Ratnavali of Kaviraja Ambikadatta Sastri, Seethapittakotadhikara: Chapter 55, Route: Oral, Dosage Form: Khanda /Granules, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: ushnajala), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Amruthadi kashaya , Reference: Bhaishajya Ratnavali of Kaviraja Ambikadatta Sastri, Seethapittakotadhikara: Chapter 55, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: Sarshapa Taila, Reference: Bhaishajya Ratnavali of Kaviraja Ambikadatta Sastri, Seethapittakotadhikara: Chapter 55, Route: Topical, Dosage Form: Taila, Dose: 100(ml), Frequency: sos, Bhaishajya Kal: Muhurmuhu, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: -(3) Medicine Name: haridrakhanda, Reference: Bhaishajya Ratnavali of Kaviraja Ambikadatta Sastri, Seethapittakotadhikara: Chapter 55, Route: Oral, Dosage Form: Khanda /Granules, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: ushnajala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
Subjects suffering from serious systemic disorders like uncontrolled diabetes mellitus, SLE, Sjogren’s syndrome, autoimmune thyroid diseases, respiratory tract infection10.
Angio edema.
Acute urticaria less than 6 weeks.
Subjects who are on steroid medications.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
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)
Pipasa (excessive thirst)
Jvara (fever)
Chhardi (vomiting)
Vibandha (constipation)
Raktalochanata (reddish discoloration of the eyes)
Dehasada (tiredness of the body)
|
1st Assessment on 1st day
2nd Assessment on 11th day
3rd Assessment on 21st day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Urticaria Activity Score |
1st Assessment on 1st day
2nd Assessment on 11th day
3rd Assessment on 21st day
|
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
Modification(s)
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
05/08/2023 |
| 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="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a Open label Comparative Clinical trial to
evaluate the efficacy of Amruthadi kashaya as an add on drug
to Haridrakhanda and Sarshapathaila. Subjects are allocated in to study and comparator
groups respectively.Minimum of 30 patients diagnosed as suffering from Sheethapitta fulfilling
the inclusion criteria irrespective of sex & religion will be selected
for the comparative study. A separate case sheet pro forma will be prepared
& subjects will be examined. They will be divided in to 2 equal
Groups A and B, where Group A will be administered with Amruthadi
kashaya 50 ml twice daily before food along with Haridrakhanda
6gm twice daily before food. In Group B, Haridrakhanda alone
will be administered in the dosage of 6gm twice daily before food Sarshapathaila will
be 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 |