A clinical study on the role of Pracchan karma, Jalaukawacharan and Kakodumbaradi lepa in the management of Shwitra(vitiligo)

Phase 1/2

Completed

• Conditions: Shwitra(Vitiligo)

• Registration Number: CTRI/2018/04/013058
• Lead Sponsor: Institute of Medical Sciences

Brief Summary

A randomized parallel trial was done with the title "A clinical study on the role of Pracchan karma, Jalaukawacharan and Kakodumbaradi lepa in the management of Shwitra(Vitiligo)". Total 100 patients were registered in the trial. Out of which 83 patients were the final participants. Patients between 16-60 years of age having Shwitra(Vitiligo)  but not on lip, scalp, neck or whole body were registerd. 25 patients were advised Pracchan therapy, 25 patients were advised  Jalaukawacharan(Leech therapy),  25 patients were advised  the topical application of Kakodumbaradi lepa. 25 patients were advised  the control drug,i.e., Tacrolimus ointment 0.1%. In patients in whom Pracchan therapy was advised, only 22 continued till completion of  the trial. In patients in whom Jalaukawacharan(Leech therapy) was advised, 20 patients continued till completion of the trial. 22 patients given Kakodumbaradi lepa continued the treatment till completion of the trial. 19 patients given Tacrolimus ointment 0.1% continued till completion of the trial. The result of the trial was very impressive with the therapies and the kakodumbaradi lepa being very effective in Shwitra(Vitiligo) patients. The Pracchan therapy and Jalaukawacharan are the therapies indicated in ancient Ayurvedic texts for letting impure blood from the site of disease manifestation. These therapies help in removal of free radicals and other toxins accumulated in the site of disease manifestation. These therapies also improve blood circulation in the site of disease manifestation leading to increased supply of nutrients and oxygen via fresh blood flow which stimulates melanocytes thus leading to improvisation of color formation process which is hampered in Shwitra(Vitiligo). The Kakodumbaradi lepa consisted of equal proportions of dried powder of Bakuchi(Psoralea corylifolia) seeds, Kakodumbar(Ficus hispida) bark and Chitrak(Plumbago zeylanica) triturated in Cow’s urine till it becomes a fine paste which is then applied on the vitiliginous patches followed by sun-exposure for 10-15 minutes. All the three ingredients and UV rays of sunlight leads to stimulation of melanogenesis. The control drug Tacrolimus ointment 0.1% is a topical calcineurin inhibitor which acts by decreasing immune response at the site of disease manifestation. It works on the basis of autoimmune pathogenesis of Vitiligo.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-12
• Last Update Posted: 2018-03-24
• Study Completion: 2018-05-03

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Dignosed cases of Vitiligo.
• Patients willing to participate in the trial and informed consent taken.

Exclusion Criteria

• Patients having lesions on lip, scalp or neck.
• Patients with complete dipigmentation all over body.
• Presence of any systemic disease.
• Presence of any other skin disease.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Day 0, 30, 60 and 90.	Day 0, 30, 60 and 90.

Secondary Outcome Measures

Name	Time	Method
Assessment was done on the basis of especially prepared proforma for assessing the safety of the procedures and the drugs	90 days

Trial Locations

Locations (1)

Sir Sundarlal Hospital; 🇮🇳 Varanasi, UTTAR PRADESH, India

Sir Sundarlal Hospital

🇮🇳Varanasi, UTTAR PRADESH, India

Anuradha Pathak

Principal investigator

9473972695

dranuradha89@rediffmail.com