Role of Panchkarma in Gout
- Conditions
- Medical and Surgical,
- Registration Number
- CTRI/2018/05/014308
- Lead Sponsor
- Uttarakhand Ayurved University
- Brief Summary
**AIMS AND OBJECTIVES:**
· The clinical evaluation of *AMRUTADHYA TAIL MATRA BASTI* in the management of Hyperuricemia.
**MATERIALS AND METHODS:**
**1.** **DRUG REVIEW:**
**AMRUTADHYA TAIL:**
· गà¥à¤¡à¥‚ची मधà¥à¤•à¤‚ हà¥à¤°à¤¸à¥à¤µà¤‚..............चैततà¥à¤¤à¥ˆà¤²à¤¾à¤—à¥à¤¯à¤®à¤®à¥ƒà¤¤à¤¾à¤¹à¥à¤°à¤¯à¤® || (च. चि. २९)
· UkkfLr rSykr ija fdafpnkS’k?ka ek:rkige……………………AA (च. सॠ. २८)
· शरीरजानां दोषाणां कà¥à¤°à¤®à¥‡à¤£ परमौषधमà¥
............................तैलं घृतं मधॠ(अ० हà¥à¥¦)
Tail is main draya to pacify vata dosh, as described. Here we are using tail in the form of maatra basti.
**2.** **TREATMENT REVIEW :**
**BASTI :**
Simply it is assume that due to self-etiology Vata gets vitiated and leads to Rakta dusti. Ultimately Rakta forms avarana in channels of Vata and both gets mutually vitiated.
Seats of Vata are mainly larger and smaller joints so; the joints are involved in this condition.
Treatment of Vatarakta described in various texts in mainly Basti Chikitsa.
न हि वसà¥à¤¤à¤¿à¤¸à¤®à¤‚ किंचिदवातरकà¥à¤¤à¤šà¤¿à¤•à¤¿à¤¤à¥à¤¸à¤¿à¤¤à¤®à¥ ।। (च. चि. २९**/**८८)4
Different type of Basti described in Ayurvedic text including Niruha Basti, Anuvasana Basti and Matra Basti. So in this study we are taken Matra Basti because of its easy application and administration.
**3.** **PLAN OF STUDY:**
Patients having Hyperuricemia and general symptoms of vata rakta will be selected from O.P.D/I.P.D of Panchakarma Department, Rishikul Campus, Haridwar. The study will be conducted on the patients randomly distributed into 2 groups of 20 patients in each group, on the basis of inclusion and exclusion criteria depending on the detailed clinical history, physical examination and other necessary investigations irrespective of their caste, creed and gender.
**A.** **INCLUSION CRITERIA:**
· Age >20 yrs. or <60 yrs.
· Patients having general symptoms of Vata Rakta
· Serum uric acid >6.0 mg/dl (for Females)
· Serum uric acid >6.8 mg/dl (for Males)
· Patient age between 20-60yrs.
· Patient fit for *Basti karma*.
**B.** **EXCLUSION CRITERIA****:**
· Secondary Hyperuricemia.
· Patient with uncontrolled diabetes.
· Tophaceous gouty arthritis.
· Patients with renal impairment.
**C.** **CRITERIA FOR WITHDRAWL****:**
· Personal matters
· Inter-current illness
· Aggravation of complaints
**D.** **SAMPLE SIZE****:** Patients will be randomly distributed in 2 groups.
**GROUP A:**
20 Patients of this group will be administered with *AMRUTADHYA TAILA*-*MATRABASTI* in 3 sittings of 15day with a gap of 7 day in between.
**GROUP B:**
20 Patients will be given **Allopurinol 150 mg** twice a day after breakfast and dinner for a period of 60 day.
**E.** **TYPE OF STUDY****:** Open randomized clinical trial.
**F.** **FOLLOW UP****:** The patients will be followed up at 15th day after the completion of total duration of therapy.
**G.** **STUDY DURATION****:** Total duration of study including follow up is of 66 days.
**CRITERIA FOR EXAMINATION AND ASSESSMENT****:**
**A.** **SUBJECTIVE PARAMETERS****:**
Symptoms of Vata Rakta will be examined and Assessed according to self made severity grading :
**1.** Kandu ( Itching)
**2.** Daah (burning)
**3.** Ruk ( Pain)
**4.** Aayam (Streching)
**5.** Toda ( tenderness )
**6.** Sphurana ( Pulsation)
**7.** Aakunchan (contraction)
| | | | | | |
| --- | --- | --- | --- | --- | --- |
|**Severity of Symptoms**
**Absent**
**Mild**
**Moderate**
**Severe**
**Very severe**
|Grading
0
1
2
3
4
**B.** **OBJECTIVE PARAMETERS****:**
**INVESTIGATIONS:**
· **S. Uric acid**
· Hb%
· T.L.C
· D.L.C
· E.S.R
· B. Sugar- Fasting and post prandial
· B. Urea
· S. Creatinine
· Urine analysis- Routine & Microscopic
These investigations will be carried out before, in between and after completion of therapy.
Ø Subjective and objective parameters will be employed for the assessment of the impact of treatment procedures in the respective group.
| | |
| --- | --- |
|Complete remission
100% relief
|Markedly improved
71%-99% relief
|Moderately improved
41%-70% relief
|Mildly improved
16%-40% relief
|Unchanged
0%-15% relief
|Worsened
<0%
**Research Proforma:** A detailed research proforma will be prepared incorporating all the points from Ayurvedic as well as modern aspect to study the patients as well as disease.
**OBSERVATION:**
The observation of patients will be carried out before, during and after completion of treatment. Little addition and exclusion may be done as per necessity of the study.
**STATISTICAL ANALYSIS:**
To obtain the efficacy of the therapy, appropriate statistical analysis will be carried out by applying following statistical teston available data:
· For inter group comparision of subjective parameter, **Mann & Whitney** will be applied.
· For inter group comparision of objective parameter, **Chai square test** will be applied.
**RESULTS & CONCLUSION:**
The results will be analyzed statistically and discussed. Conclusion will be made on the basis of observation which is done on objective parameters.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 40
Fulfilling Diagnostic Criteria of vatarakta.
Secondary Hyperuricemia.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method •Marked improvement : 0% to 25 % •Marked improvement : 0% to 25 % | •Moderate improvement : 25 % to 50 % | •Mild improvement : 50% to 75 % | •No improvement : 75% to 100% •Moderate improvement : 25 % to 50 % •Marked improvement : 0% to 25 % | •Moderate improvement : 25 % to 50 % | •Mild improvement : 50% to 75 % | •No improvement : 75% to 100% •Mild improvement : 50% to 75 % •Marked improvement : 0% to 25 % | •Moderate improvement : 25 % to 50 % | •Mild improvement : 50% to 75 % | •No improvement : 75% to 100% •No improvement : 75% to 100% •Marked improvement : 0% to 25 % | •Moderate improvement : 25 % to 50 % | •Mild improvement : 50% to 75 % | •No improvement : 75% to 100%
- Secondary Outcome Measures
Name Time Method •Marked improvement : 0% to 25 % •Moderate improvement : 25 % to 50 %
Trial Locations
- Locations (1)
Rishikul campus Hospital
🇮🇳Hardwar, UTTARANCHAL, India
Rishikul campus Hospital🇮🇳Hardwar, UTTARANCHAL, IndiaDr Alok Kumar SrivastavaPrincipal investigator9045087121virgo.alok@gmail.com