An Open Siengle Arm Clinical Trail to Determine the Therapeutic Effect of Kottai Karanthai Illai Kattu (Bandage) In the Management of Kuthikaal Vaatham (Plantar Fasciitis)

BACKGROUND:

Siddha system of medicine is one of the ancient systems of medicine in South India. The physical health of human body is maintained by the three humours namely Vaatham,Pitham,Kabam called Uyirthathukkal. The imbalance of Uyirthathukkal leads to diseases. In Siddha system of medicine, the diseases are classified according to Mukkutram theory.

According to classic Siddha literature Yugi Vaithiya Kaaviyam symptoms of Kuthikaal Vatham correlated with plantar fasciitis in modern science. Plantar fasciitis occurs due to irritation of the plantar fascia origin at the medial calcaneal tuberosity of the heel and its surrounding perifascial structures. The pathophysiology is mainly related to chronic overuse and repetitive stress on plantar fascia which leads to micro tears, inflammation and periostitis. Plantar fasciitis occurs in about 10% of the general population, with 83% of these patients being active working adults between 25 and 65 years.Application and covering of a specially prepared topical medicine made up of crude plants, birds, fermented water or inorganic substances on the affected area is known as Kattu.According to the Siddha literature Therayar vaithiyam 1000 Kottai karanthai illai kattu (Bandage) is used to treat kuthikal vaatham. The leave of Kottai karanthai (Sphaeranthus indicus) are known for potential anti-inflammatory, anti-arthritic and analgesic activities.So, this study aims to clinically evaluate the Effect of kottai karanthai ilai kattu in the management of kuthikaal vaatham.

OBJECTIVE:

To determine the therapeutic Effect of Kottai karanthai illai kattu (Bandage) in reducing the clinical signs and symptoms of Kuthikaal vaatham (Plantar Fasciitis) assessed with Foot function index scale.

METHODOLOGY:

Study design : Interventional study – Pilot clinical study.

Study period : 6 months.

Study place : Pura maruthuvam OPD, Ayothidoss Pandithar Hospital,

National Institute of Siddha, Tambaram Sanatorium,

Chennai-47.

Sample size : 10 participants.

STUDY ENROLLMENT:

• Participants reporting at the Puramaruthuvam OPD with the clinical symptoms of Kuthikaal vaatham, examined clinically and will be enrolled in the study based on the inclusion and exclusion criteria by using the screening proforma. The participants who were enrolled would be informed about the study, possible outcomes and treatment methodologies in their own language and the informed consent will be obtained by using consent form .Complete clinical assessment and laboratory investigation will be recorded by using the concerned forms.

CONDUCT OF THE STUDY:

After the enrollment of patient with brief explanation and informed consent, the treatment procedure will be carried out under the guidance of guide.The trial medicine Kottai karanthai illai kattu (External application) will be done continuously for 3 days. If the pain persists even after 3 days of kattu the treatment will be continued furtherly to ensure improvement of clinical signs and symptoms. The prognosis will be assessed by using Visual analog scale and Foot Function Index Score before and after treatment.After the completion of study, the participant will be advised to visit the OPD up to 1 month for observation.Laboratory investigations and radiological investigation will be done before and after the treatment.Safety of the drug will be assessed by monitoring any adverse reactions.

DATA ANALYSIS:

After enrolling the participant in the study, a separate file for each participant and all forms will keep in the file. Study No. and Participants No. will be written on the top of file for easy identification. Whenever the participants visits Puramaruthuvam OPD during the study period, the respective participant’s file will take and necessary entries was made at the assessment form or other suitable form. The data entry will be monitored in the presence of guide and HOD. The collected data will be entered using MS excel software in computer. The data will be statistically analyzed. All forms will be scrutinized by the statistician for logical errors and incompleteness of data to avoid any bias. No modification in the results will be permitted for unbiased reports.

ADVERSE EFFECT/SERIOUS EFFECT MANAGEMENT

If the trial participant develops any adverse reaction, he/she would be immediately withdrawn from the trial and proper management will be given at the Puramaruthuvam IPD of National Institute of Siddha and the same will informed to the Pharmaco-vigilance committee of NIS.

OUTCOME:

The outcome of the study may reveal the therapeutic Effect of kottai karanthai illai kattu (Bandage) in the management of kuthikaal vaatham (Plantar fasciitis) assessing the Visual analogue scale and Foot function index score.