A Randomized controlled clinical trial to compare the efficacy of Langladyam Loham with Kaishor Guggul in the management of Vatarakta.
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- To compare the efficacy of Langladyam Loham with Kaishor Guggul in the management of Vatarakta,
Study Overview
Brief Summary
Gout is a medical condition usually characterized by recurrent attack of acute inflammatory arthritis – a red, tender, hot, swollen joint. The metatarsal – Phalangeal joint at the base of big toe is most commonly affected. Increase production of uric acid as cause of gout is seen in only 10 to 15 % of subject and 80-90% uric acid excretion is impared. The deposition of Mono-sodium Urate crystal in joints causes Gouty Arthritis, in soft tissues causing tophi and tenosynovitis.
The general prevalence of Gout is 1-4% of the general population. It occurs in men 2-6 folds more than women. World wild incidence of Gout increases gradually due to poor dietary habits such as fast food, lack of exercises , increase incidence of abesity and metabolic syndrome. In Ayurveda the nearest co-relation of Gout can be made with Vatarakta. It is a disease of MadhyamRoga Marga as it affects mainly Sandhis. (Parvasandhis). Vatarakta is caused by Adhyashana , Virudhaashana, Divasawpna, etc. Due to these Nidanas vata and rakta gets vitiated. Aggravated vata is blocked by vitiated Raktas circulate very fast all over the body due to the Sukshma and Drava Guna of Vata and Rakta respectively and undergo DoshaDushyaSammurchana in Sandhi Sthana specifically in Kar, Pada, Angula sandhi. The classical symtoms are Vatarakta kandu, Shawaythu , Bheda, Toda, Shula, Kathinya, Sparshasahavta. Ayurveda can provide a very good holistic treatment option. Today there is need to fine the drug which gives long term relief without any adverse effect.
LangdadyLoham is one of the Kalpa mention for Vatarakta Chikitsa , It has anti inflammatory properties which helps to reduce the pain. Langli act as Shoolprashaman , KaphaVatashamak. This drugs shows antagonistic action on Prakupit Vata doshas & Rakta dhatu involved on Vatarakta. This Kalpa is proposed to shows an efficient action on pathology of this disease. The ingredients used in the LangladyamLoham are easily available and cost effective. Comparatively by using the Ayurvedic formulation and dietary regulation the sign and symptoms of Vatarakta are decreases without any side effect. In previous study Kaishor Guggul was found be to be Significant in the management of of Vatarakta. The present study is carried out to study the efficacy of an ayurvedic herbal compound LangladyLoham on biochemical markers- uric acid level , CBC, CRP, ESR.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- None
Eligibility Criteria
- Ages
- 20.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patient having signs and symptoms or Vatarakta such as Sandhi Shula (pain), Sandhi Shotha (Swelling), Sparshaashatva (Tenderness), Twak Vaivarnya (Discolouration of skin.
- •Patient from age group between 20-65 years old, irrespective of their sex, religion geographical area.
- •Patient having uric acid level greater than 7 mg/dl in male ^ 6 mg/dl in female.
Exclusion Criteria
- •Patient having severe disorder like renal disorder-acute and chronic renal failure, poly nephritic syndrome, Liver disorder, Liver cirrhosis, Hepatitis, Neurological Disorder.
- •Patient having sexual transmitted disease and immunosuppressant disorder.
- •Lactating Mothers, Pregnant Women.
- •Patient having Rheumatoid arthritis, Psoriatic arthritis , any joint replacement surgery, and any chronic illness.
Outcomes
Primary Outcomes
To compare the efficacy of Langladyam Loham with Kaishor Guggul in the management of Vatarakta,
Time Frame: Duration of the study- 36 months. | Duration of treatment: 30 days follow up 7th day, 14th day,21st day and 31st day
To evaluate the efficacy of Langladyam Loham on biochemical markers and to assesst the side effect if any.
Time Frame: Duration of the study- 36 months. | Duration of treatment: 30 days follow up 7th day, 14th day,21st day and 31st day
Secondary Outcomes
- To study adverse effect if any.(To assess the efficacy of Langladyam Loham And Kaishor Guggul on biochemical markers)
Investigators
Dr Pritesh Jaiswal
Shri Ayurved Mahavidyalaya