Investigator(s)
| Submitter |
Lungten Norbu Tang Primary Health Centre Lungten Norbu 
|
| Principal Investigator |
Lungten Norbu Tang Primary Health Centre Lungten Norbu
|
| Co-Investigator(s) |
Sonam Yuden Trongsa District Hospital Sonam Yuden
|
| Co-Investigator(s) |
Sonam Choden Sangbaykha Primary Health Centre Sonam Choden
|
| Co-Investigator(s) |
Yeshi Choden Khengar Primary Health Center Yeshi Choden
|
| Co-Investigator(s) |
Sonam Wangzin Rabjay Eastern Regional Referral Hospital, Mongar, Bhutan Sonam Wangzin Rabjay
|
| Co-Investigator(s) |
Tempa Gyeltshen Faculty of Traditional Medicine, Khesar Gyalpo University of Medical Science of Bhutan, Thimphu, Bhutan Tempa Gyeltshen
|
| Co-Investigator(s) |
Thinley Dorji Department of Internal Medicine, Central Regional Referral Hospital, Gelephu, Bhutan Thinley Dorji
|
Title(s) and abstract
| Scientific title | Impact of Golden Needle Therapy among patients with Langshu skin lesions presenting at selected Traditional Medicine Units in Bhutan: an observational cohort study |
| Public title | Impact of Golden Needle Therapy among patients with Langshu skin lesions presenting at selected Traditional Medicine Units in Bhutan. |
| Background | Superficial mycoses, caused by dermatophytes like Trichophyton, Microsporum and Epidermophyton, account for approximately 325 million infections globally. These fungal infections present as itchy, red, ring-shaped rashes and are highly contagious, transmitted through direct contact with infected individuals or contaminated surfaces. According to WHO, 20-25% of people worldwide have superficial fungal infections at any time. The most common clinical manifestation is tinea corporis (78.1%), followed by tinea cruris (10.1%) and other forms. While not life-threatening, these infections significantly impact quality of life. In Bhutan, skin diseases ranked as the second most common health condition in 2024, with 56,852 cases nationwide. Fungal infections, locally called "Langshu," are diagnosed by their characteristic circular lesions with red margins. Diagnostic capabilities include basic KOH microscopy, though this isn't available in all facilities, especially rural areas. Standard treatments include topical antifungals like clotrimazole and oral medications for severe cases. Bhutan's traditional medicine system (Sowa Rigpa) is fully integrated into the national healthcare system. Within this framework, Langshu is understood as an imbalance of bodily energies treated with various traditional therapies. Serkhab (Gold Needle Therapy) is widely practiced, involving the application of heated gold needles to specific points on and around the lesion to stimulate circulation and balance energies. Despite widespread cultural acceptance and anecdotal success, scientific evidence supporting Serkhab's efficacy remains limited. As Bhutan strengthens its commitment to evidence-based traditional medicine, there's a growing need to scientifically validate this practice. |
| Objectives | Aims To describe the impact of Gold Needle Therapy (Serkhap) in treating Langshu skin infections with circular lesions having red margins, among the patients presenting in selected hospitals in Bhutan. Objectives Among patients with Langshu who are treated with weekly sessions of Serkhap at selected Traditional Medicine Units between May to August, 2025 to describe the: Socio-demographic profile of patients; Clinical profile of the disease (diameter of the lesion, pruritus, area of body affected) over the course of therapy; Level of satisfaction with the therapy. |
| Study Methods | Study design This is an observational cohort study. Study setting This study will include patients presenting at Bumthang, Dewathang, Tashicholing, Gomtu and Trongsa Hospitals between June and August 2025. Study population, sample size and sampling method All patients above 16 years, who are diagnosed with Langshu and positive fungal KOH mount visiting TM Units with complete sampling. The sample size was calculated for proportions using OpenEpi. Version 3. For a population of 6040 cases, an expected outcome of 6% of cases with skin diseases and margin of error of 5%, the sample size was 86. With a dropout rate of 20%, the final sample size was 103 cases. Data collection method All patients above 16 years, who are diagnosed with Langshu and positive fungal KOH mount visiting Traditional Medicine Units. A proper consent will be taken from each and every patient prior to this study. Questionnaire will be administered by the data collector. Data analysis and statistics Data will be entered in REDCap. Data analysis will be done using STATA (version 13.0, StataCorp LP USA). Categorical variables will be summarized using frequency and proportions and continuous variables will be summarized using mean ±standard deviation or median and interquartile range, whichever applicable. Ethics considerations Ethics approval from relevant bodies will be sought accordingly. |
| Expected outcomes and use of results | The expected outcome from the data analysis is aimed to bring evidence-based practices in adopting gold needle therapy (serkhab) in the hospital setting. In addition, with comprehensive underlying of clinical profile of disease such lesion, pruritic, etc. While this study may not have direct benefit to the patient, the overall summary findings from this study will help in the development of policy and guideline related to the use of serkhab in the treatment of langshu. If there is good outcome observed, the findings may be shared with other uses. |
| Keywords | Fungal infection, Tinea Corporis, skin disorder, Pruritus, discoloration |
Research Details
| Student research | No |
| Start Date | 01-Jun-2025 |
| End Date | 01-Aug-2025 |
| Key Implementing Institution | Ministry of Health |
| Multi-country research | No |
| Nationwide research | Yes, with randomly selected geographical areas |
| Bhutan | |
| Research Domain(s) | Communicable Disease Research |
| Research field(s) | Infectious Disease |
| Involves human subjects | Yes |
| Operational Research | |
| Data Collection | Primary data |
| Proposal reviewed by other Committee | No |