| CTRI Number |
CTRI/2025/03/081946 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
06/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study conducted to see the effect of Tilakusumadi and Sarjarasadi lepa with Manibhadra guda in the management of vipadika with special reference to Palmo-plantar psoriasis. |
|
Scientific Title of Study
|
An Open Labelled Comparative Clinical Study to Evaluate the Effect of Tilakusumadi and Sarjarasadi lepa with Manibhadra guda in the management of vipadika with special reference to Palmo-plantar psoriasis. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sudha Hatti |
| Designation |
PG Scholar Kayachikitsa |
| Affiliation |
BVVS Ayurved Medical College and Hospital Bagalkot |
| Address |
Department of PG Studies in Kayachikitsa BVVS Ayurved Medical College and Hospital BVVS Campus Bagalkot
Bagalkot
KARNATAKA
587101
India |
| Phone |
7348805466 |
| Fax |
|
| Email |
sudhah299@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S S Kalyani |
| Designation |
professor |
| Affiliation |
BVVS Ayurved Medical College and Hospital Bagalkot |
| Address |
Department of PG Studies in Kayachikitsa BVVS Ayurved Medical College and Hospital BVVS Campus Bagalkot
Bagalkot
KARNATAKA
587101
India |
| Phone |
9591273858 |
| Fax |
|
| Email |
drleelakalyani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S S Kalyani |
| Designation |
professor |
| Affiliation |
BVVS Ayurved Medical College and Hospital Bagalkot |
| Address |
Department of PG Studies in Kayachikitsa BVVS Ayurved Medical College and Hospital BVVS Campus Bagalkot
Bagalkot
KARNATAKA
587101
India |
| Phone |
9591273858 |
| Fax |
|
| Email |
drleelakalyani@gmail.com |
|
|
Source of Monetary or Material Support
|
| BVVS AYURVEDA MEDICAL COLLEGE AND HOSPITAL BAGALKOT KARNATAK 587101 |
|
|
Primary Sponsor
|
| Name |
BVVS AYURVED MEDICAL COLLEGE AND HOSPITAL |
| Address |
BVVS AYURVED MEDICAL COLLEGE AND HOSPITAL BAGALKOT 587101 |
| 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 SUDHA HATTI |
BVVS Ayurved Medical College and Hospital |
Department of PG Studies in Kayachikitsa BVVS Ayurved Medical College and Hospital BVVS Campus Bagalkot
Bagalkot
KARNATAKA |
7348805466
sudhah299@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BVVS AYURVED MEDICAL COLLEGE AND HOSPITAL BAGALKOT |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: VIPADIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Lepa application | (Procedure Reference: Bhaishajya Ratnavali Kushta chikitsa , Procedure details: Patient is made to sit down in comportable position then the prepared Lepa is applied on the palm & sole with 1/4 th Angula thickness as local application in the evening until the Lepa dries )
(1) Medicine Name: Tilakusumadi lepa , Reference: Bhaishajya Ratnavali,Kushta chikitsa chapter 54/39, Route: Topical, Dosage Form: Kalka/ Paste, Dose: 00(NA), Frequency: od, Duration: 30 Days | | 2 | Comparator Arm | Procedure | - | Sarjarasadi Lepa | (Procedure Reference: Bhaishajya Ratnavali Kushta chikitsa , Procedure details: Patient is made to sit down in comportable position then the prepared Lepa is applied on the palm & sole with 1/4 th Angula thickness as local application in the evening until the Lepa dries )
(1) Medicine Name: Sarjarasadi Lepa , Reference: Bhaishajya Ratnavali Kushta chikitsa , Route: Topical, Dosage Form: Kalka/ Paste, Dose: 00(NA), Frequency: od, Duration: 30 Days | | 3 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Manibhadra Guda, Reference: Asthanga Hrudaya Kushta chikitsa , Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 6(g), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Sukoshna jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria:
1)Patient presenting with classical sign and symptoms of Vipadika.
2)Subjects of age between 20 to 70 year irrespective of age. |
|
| ExclusionCriteria |
| Details |
Exclusion criteria:
1)Patients associated with other type of Kushta.
2)Uncontrolled diabetic and hypertension.
3)Pregnant women and lactating mother. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To know the effect of Tilakusumadi and Sarjarasadi Lepa with Manibhadra Guda in the management of Vipadika with special reference to Palmo-plantar psoriasis. |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Aims and Objectives of the study:
1.To evaluate the effect of Tilakusumadi and Sarjarasadi lepa with Manibhadra Guda in the management of Vipadika with special reference to Palmo-plantar psoriasis.
2.To evaluate the effect of Tilakusumadi lepa with Manibhadra Guda in the management of Vipadika with special reference to Palmo-plantar psoriasis.
3.To evaluate the effect of Sarjarasadi lepa with Manibhadra Guda in the management of Vipadika with special reference to Palmo-plantar psoriasis. |
30 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
10/04/2025 |
| 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)
|
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
|
All the skin diseases in Ayurveda have been considered under the heading kushta which is one among the Ashta Mahagada. Vipadika is one of the kshudra kushta .It is a Vatakapha pradhan Tridoshaja Twakvikara.It is characterized by Pani pada sphutana, Tivra vedana,Manda kandu, Saraaga pitika.Acharya Susruta has also explained similarly with one more symptoms Daha. Due to Nidana Sevana,the thridoshas are vitiated and cause vitiation of Twak , Rakta, Mamsa and Ambu end up in manifestation of kushta. Based on the similar clinical features,Vipadika Kushta can be compared with Palmoplantar Psoriasis. Prevalence rate of Palmoplantar variant of psoriasis comprises 3% to 4% of all cases of Psoriasis, which affects 2% to 5% of the population. Palmoplantar psoriasis is a chronic variant of psoriasis that characteristically affects the skin of the palms and soles and produces significant functional disability. It features hyperkeratotic,pustular. Palmoplantar psoriasis is considered to be caused by a combination of genetic and environmental factors. Modern medicine treatment modalities includes oral retinoids with or without photochemotherapy, corticosteroids and cyclosporine these may be helpful in symptomatic management of disease and symptoms may reoccur by triggering factors and these medicine are having its own side effects in long term use so there is need to find safe and effective medicine in the management of vipadika. In classics Shodhan, Shamana, Bahirparimarjan Chikitsa are explained.Lepa are applied against the hair follicular direction to facilitate quicker and better absorption .Tilakusumadi lepa mentioned in Bhaishajya Ratnavali is indicated in Vipadika. having ingredients like Tila pushpa, Saindhava lavana,Gomutra,Katu tail mainly having Tikta, Kashya rasa, Laghu, Ruksha guna act as Kushtahara, Shodhan,Ropana , Vatakaphahara,Twachya. Sarjarasadi lepa mentioned in Bhaishajya Ratnavli is indicated in Vipadika having ingredients like Sarja rasa, Saindhava lavana, Guda, Madhu, Guggulu,Gairika churna, Go ghrita,Sikta having Tikta, Kashaya rasa and Laghu, Ruksha,Snigdha guna and act as Kushtaghan,Tridoshahara, Shodhan,Ropana,Twachya. Manibhadra Guda mentioned in Ashtanga Hrudaya is indicated in Kushta.Having ingredients like Vidanga,Amalaki,Abhaya,Trivruta,Guda, mainly having Tikta,Kashaya rasa and Laghu,Ruksha guna and act as Kushtaghna Anulomak,Virechak,Rasayana property. Hence present study will be aimed to evalute and compare the effect of Tilakusumadi and Sarjarasadi lepawith Manibhadra Guda in Vipadiak with special reference to Palmo-plantar psoriasis. |