Panchatikta Ghrita Guggulu in Kitibha Kushtha (plaque psoriasis)
An open-label interventional study of Panchatikta Ghrita Guggulu with external Nimba Taila application in Kitibha Kushtha (chronic plaque psoriasis)
- Sponsor
- All India Institute of Ayurveda (intramural)
- Principal investigator
- Dr. N. Deshpande · Associate Professor, Shalya Tantra
- Condition studied
- Plaque psoriasis (Kitibha Kushtha)
- Design
- Single arm, open label
- Intervention
- Panchatikta Ghrita Guggulu 2 tablets thrice daily + Nimba Taila, 12 weeks
- Comparator
- Single arm — no comparator
Study lifecycle
Protocol through close-out. Completed stages are filled, the current stage pulses.
Protocol
01 Oct 2017
EC Approval
24 Jul 2018
CTRI Registration
17 May 2019
Site Activation
09 Mar 2020
Screening
30 Dec 2020
Enrolment
23 Oct 2021
currentFollow-up
—
Close-out
—
Enrolment against target
11 of 20 participants (55%)
Screening funnel
Screened through to follow-up completion
Site-wise enrolment
Real institutes from the NPvCC network
| Site | Tier | HFR id | Enrolled | Share |
|---|---|---|---|---|
| All India Institute of Ayurveda, New DelhiNew Delhi · Ayurveda | NPvCC | IN0710000123 | 4 | |
| National Institute of HomoeopathyKolkata · Homoeopathy | IPvC | IN1910000689 | 7 |
Consent tracking
Versioned, specific and withdrawable — the DPDP requirement
Participants consented
11
Current consent version
v1.3
Re-consent required
4
Withdrawn
0
4 participants consented on an earlier version and must be re-consented against v1.3 before their next visit.
Protocol deviations
1 open of 2 recorded
Consent process
Consent form signed but date of signature not recorded by witness
DEV-KIT-01 · 29 Jun 2026
Procedure
Shodhana procedure sequence altered on clinical grounds, not pre-documented
DEV-KIT-02 · 22 Aug 2026
Data queries
6 open · 2 answered · 17 closed
Result outside reference range with no interpretation recorded.
Laboratory · LBORRES (SGPT) · AIIA-KIT-DEL-008
Systolic BP of 210 mm[Hg] not flagged as an AE — clinically significant?
Vital signs · VSORRES (SYSBP) · AIIA-KIT-DEL-008
Systolic BP of 210 mm[Hg] not flagged as an AE — clinically significant?
Vital signs · VSORRES (SYSBP) · AIIA-KIT-KOL-003
Dose recorded as 0 for Visit 4 with no interruption reason.
Exposure · EXDOSE · AIIA-KIT-DEL-006
Concomitant medicine entered as a brand name — please give the generic.
Concomitant meds · CMTRT · AIIA-KIT-DEL-004
AE onset date precedes the first dose date. Please verify.
Adverse events · AESTDTC · AIIA-KIT-DEL-004
Hospitalisation noted in the narrative but AESER recorded as N. Please reconcile.
Adverse events · AESER · AIIA-KIT-DEL-009
AE onset date precedes the first dose date. Please verify.
Adverse events · AESTDTC · AIIA-KIT-DEL-006
Birth date inconsistent with the age recorded at screening — please confirm.
Demographics · BRTHDTC · AIIA-KIT-KOL-007
Dose recorded as 0 for Visit 4 with no interruption reason.
Exposure · EXDOSE · AIIA-KIT-KOL-007
Concomitant medicine entered as a brand name — please give the generic.
Concomitant meds · CMTRT · AIIA-KIT-KOL-001
Subject marked completed but Visit 6 is missing.
Disposition · DSDECOD · AIIA-KIT-KOL-011
Dose recorded as 0 for Visit 4 with no interruption reason.
Exposure · EXDOSE · AIIA-KIT-DEL-009
Subject marked completed but Visit 6 is missing.
Disposition · DSDECOD · AIIA-KIT-KOL-001
Concomitant medicine entered as a brand name — please give the generic.
Concomitant meds · CMTRT · AIIA-KIT-KOL-010
Birth date inconsistent with the age recorded at screening — please confirm.
Demographics · BRTHDTC · AIIA-KIT-DEL-008
AE onset date precedes the first dose date. Please verify.
Adverse events · AESTDTC · AIIA-KIT-KOL-003
AE onset date precedes the first dose date. Please verify.
Adverse events · AESTDTC · AIIA-KIT-DEL-008
Result outside reference range with no interpretation recorded.
Laboratory · LBORRES (SGPT) · AIIA-KIT-DEL-004
Systolic BP of 210 mm[Hg] not flagged as an AE — clinically significant?
Vital signs · VSORRES (SYSBP) · AIIA-KIT-KOL-007
Result outside reference range with no interpretation recorded.
Laboratory · LBORRES (SGPT) · AIIA-KIT-DEL-009
Concomitant medicine entered as a brand name — please give the generic.
Concomitant meds · CMTRT · AIIA-KIT-DEL-004
AE onset date precedes the first dose date. Please verify.
Adverse events · AESTDTC · AIIA-KIT-DEL-004
Concomitant medicine entered as a brand name — please give the generic.
Concomitant meds · CMTRT · AIIA-KIT-KOL-001
AE onset date precedes the first dose date. Please verify.
Adverse events · AESTDTC · AIIA-KIT-KOL-003
Enrolled participants
De-identified by construction — identifier, sex and age only. No name, address or contact data exists in this system.
| USUBJID | Site | Status | Sex | Age | Planned arm | Consent (RFICDTC) | Ref. start (RFSTDTC) | Visits |
|---|---|---|---|---|---|---|---|---|
| AIIA-KIT-KOL-001 | KOL | on-study-intervention | F | 63 | Interventional arm | 2026-05-23 | 2026-05-27 | 4/8 |
| AIIA-KIT-KOL-002 | KOL | on-study | F | 29 | Interventional arm | 2026-03-22 | 2026-03-26 | 1/8 |
| AIIA-KIT-KOL-003 | KOL | follow-up | M | 68 | Interventional arm | 2026-06-14 | 2026-06-19 | 3/8 |
| AIIA-KIT-DEL-004 | DEL | on-study-intervention | F | 38 | Interventional arm | 2026-08-03 | 2026-08-04 | 2/8 |
| AIIA-KIT-KOL-005 | KOL | on-study-intervention | M | 39 | Interventional arm | 2026-08-23 | 2026-08-25 | 2/8 |
| AIIA-KIT-DEL-006 | DEL | on-study | F | 45 | Interventional arm | 2026-05-17 | 2026-05-20 | 5/8 |
| AIIA-KIT-KOL-007 | KOL | on-study-intervention | M | 34 | Interventional arm | 2026-05-01 | 2026-05-06 | 2/8 |
| AIIA-KIT-DEL-008 | DEL | on-study-intervention | F | 42 | Interventional arm | 2026-04-27 | 2026-04-30 | 6/8 |
| AIIA-KIT-DEL-009 | DEL | on-study-intervention | M | 31 | Interventional arm | 2026-08-01 | 2026-08-02 | 1/8 |
| AIIA-KIT-KOL-010 | KOL | follow-up | F | 45 | Interventional arm | 2026-04-26 | 2026-05-02 | 6/8 |
| AIIA-KIT-KOL-011 | KOL | on-study-intervention | F | 36 | Interventional arm | 2026-07-25 | 2026-07-30 | 6/8 |
2 adverse events recorded on this study · 1 serious — open in Pharmacovigilance