A Comparative Clinical Study to Evaluate the Efficacy of Shaman Yoga and Saindhavadi Taila Matra Vasti in the Management of Amavata w.s.r. Rheumatoid Arthritis
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- To assess the effect of therapy subjectively and objectively, all
研究概览
简要总结
The present study entitled “****A comparative clinical study to evaluate the efficacy of Shaman Yoga and Saindhavadi Taila Matra Vasti in the management of Amavata w.s.r. Rheumatoid Arthritis†is presented under following headings:
-
Introduction
-
Review of Literature
· Ayurvedic Review
· Modern Review
· Drug Review
-
Materials and Methods
-
Observation and Results
-
Discussion
-
Summary and conclusion
-
References
-
Appendices
INTRODUCTION
Nowadays erroneous dietary habits, lifestyle and environment have led to various autoimmune disorders i.e Amavishajanya Vikaras and ‘Amavata’ is one among them. The clinical presentation of Amavata is similar to Rheumatoid arthritis.
In Allopathic system of medicine the treatment of Rheumatoid arthritis involves mainly the use of NSAIDs (Non –steroidal anti-inflammatory drugs), DMARDs (Disease Modifying Anti-Rheumatic Drugs), Biologics and Corticosteroids. It is seen that they provide symptomatic relief and are beneficial in acute conditions but they have many side- effects thus adding to the misery of the patients Also, they show inefficiency in preventing relapses and bone deformities..
In Ayurveda, many approaches are in practice to treat Amavata but still it remains a challenging problem. Hence, the study was planned for better management of Amavata patients with enhanced quality of life.
DRUG REVIEW
Hingwadi Churna**, Rasna –Dashmula Kwatha and** Saindhavadi Taila Matra Vasti1 were selected to evaluate their role in the management of Amavata.
1. HINGWADI CHURNA
“ **हिंगà¥****चवà¥à¤¯à¤‚****विडं****शà¥à¤£à¥à¤ ी****कृषà¥à¤£à¤¾à¤œà¤¾à¤œà¥€**सपौषà¥à¤•रमॠ| â€
**à¤à¤¾à¤—ोतà¥à¤¤à¤°à¤®à¤¿à¤¦à¤‚****चूरà¥à¤£à¤‚**पीतंवातामजिदà¥à¤à¤µà¥‡à¤¤à¥|| **(**Chakra. Amavata Chi /24)
2. RASNA –DASHMULA KWATHA
“ दशमूलामृतैरणà¥à¤¡****-रासà¥à¤¨à¤¾à¤¨à¤¾à¤—रदारà¥à¤à¤¿à¤ƒ| â€
**कà¥à¤µà¤¾à¤¥à¥‹****रà¥à¤µà¥‚कतैलेन****सामं****हनà¥à¤¤à¥à¤¯à¤¨à¤¿à¤²à¤‚**गà¥à¤°à¥‚मॠ|| **(****Chakra. Amavata Chi /**5)
3. SAINDHAVADI TAILA
सैनà¥à¤§à¤µà¤‚देवकाषà¥à¤ ञà¥à¤šà¤µà¤šà¤¾****शà¥à¤£à¥à¤ ीचकटफलमॠ|
**शताहà¥à¤µà¤¾****मà¥à¤¸à¥à¤¤à¤•ं****चवà¥à¤¯à¤‚****मेदे****मलहरं**तà¥à¤°à¤¿à¤µà¥ƒà¤¤à¥ ||
**हिजà¥à¤œà¤²à¤¸à¥à¤¯****तà¥à¤µà¤šà¤‚****बालं****चितà¥à¤°à¤•ं**बà¥à¤°à¤¹à¥à¤®à¤¯à¤·à¥à¤Ÿà¤¿à¤•ा |
शटीविडङà¥à¤—मधà¥à¤•ंरेणà¥à¤•ाsतिविषारà¥à¤µà¥ ||
**अमà¥à¤¬à¤·à¥à¤ ा****नीलिनी**दनà¥à¤¤à¥€à¤®à¥‚लंमरिचमेवच |
अजमोदापिपà¥à¤ªà¤²à¥€à¤šà¤•à¥à¤·à¥à¤ ंरासà¥à¤¨à¤¾à¤šà¤—à¥à¤°à¤¨à¥à¤¥à¤¿à¤•मॠ||
à¤à¤·à¤¾à¤•रà¥à¤·à¤®à¤¿à¤¤à¥ˆà¤ƒà¤•लà¥à¤•ैःशनैरà¥à¤®à¥ƒà¤¦à¥à¤µà¤¿à¤—à¥à¤¨à¤¨à¤¾à¤ªà¤šà¥‡à¤¤à¥ |
**पà¥à¤°à¤¸à¥à¤¥à¤žà¥à¤š****कटà¥à¤¤à¥ˆà¤²à¤¸à¥à¤¯****मूरà¥à¤šà¥à¤›à¤¿à¤¤à¤¸à¥à¤¯**यथाविधि ||
**à¤à¤¤à¤¤à¥à¤¤à¥ˆà¤²à¤µà¤°à¤‚****शà¥à¤°à¥‡à¤·à¥à¤ मà¤à¥à¤¯à¤™à¥à¤—ातà¥**सरà¥à¤µà¤µà¤¾à¤¤à¤¨à¥à¤¤à¥ |
**विशेषेणामवातेषà¥**कटीजानूरà¥à¤¸à¤¨à¥à¤§à¤¿à¤·à¥ || **(**Bh. R. 29/209-215)
MATERIALS AND METHODS
The aims and objectives of the study were:
-
To study the aetiopathogenesis of Amavata.
-
To assess the efficacy of Hingwadi churna and Rasnadashmulakwatha on Amavata.
-
To assess the efficacy of Saindhavadi Taila Matra Vasti on Amavata.
-
To compare the clinical efficacy of Shaman Yoga and the combined effect of Shaman
Yoga along with Saindhavadi Taila Matra Vasti in the management of Amavata.
SELECTION OF THE PATIENTS
The study comprised of 45 patients of Amavata.
SELECTION OF SAMPLE: - Randomized Sampling
TYPE OF STUDY: Single Blind
DURATION OF STUDY: 60 days
DOSE OF DRUG
- Hingwadi Churna - 5 gm b.d. with lukewarm water 1 hour before meal.
- Rasna –Dashmula Kwatha- 40 ml b.d. 1 hour after meal.
- Saindhavadi Taila Matra Vasti- 60 ml once daily for 8 days, followed by an interval of 7 days . Again Vasti was given once daily for 8 days followed by gap of 7 days. Same cycle was repeated next month.
D****RUG TRIAL SCHEDULE
The selected patients for trial were randomly divided into following 3 groups.
GROUP A- Patients were treated with Hingwadi Churna and Rasna –Dashmula Kwatha.
GROUP B - Patients were treated with Saindhavadi Taila Matra Vasti alone.
GROUP C - Patients were treated with Saindhavadi TailaMatra Vasti along with Hingwadi
Churna and Rasna–Dashmula Kwatha.
SUBJECTIVE:
The subjective assessment was done on the basis of improvement in following signs and symptoms of Amavata as described in classics:
| 1. |
Sandhishula (Joint pain)
Jaadya (Morning stiffness)
|2.
Sandhishotha (Joint swelling)
Sparshasahyata (Tenderness)
|3.
Gaurav (Heaviness in the body)
Apaaka (Indigestion)
|4.
Jwara (Fever)
Bahumutrata (Frequency of micturition)
|5.
Aruchi (Loss of appetite)
Utsahahani (Loss of vigour)
OBJECTIVE:
I. Investigations
· Hb, TLC, DLC, ESR.
· RA Factor , CRP
II. Functional assessments
· Grip strength
· Foot pressure
· Goniometry (Range of motion)
RESULTS
COMPARATIVE ASSESMENT OF % RELIEF IN SUBJECTIVE PARAMETERS
| Symptoms |
% Relief
|Group A
Group B
Group C
|Visual Analogue Scale
47.5
7.3
53.8
|Pain Intensity
60.0
38.3
64.2
|Pain Frequency
7.3
26.0
47.4
|Pain Duration
50.0
25.0
62.3
|Sandhishotha
82.8
47.6
88.0
|Gaurav
76.2
58.8
94.7
|Jwara
77.8
83.3
100.0
|Aruchi
92.8
70.0
85.7
|Jadya
58.1
39.1
64.3
|Sparshasahyata
77.8
26.3
79.3
|Apaka
76.2
64.7
92.6
|Bahumutrata
25.0
20.0
75
|Utsahahani
14.3
27.3
58.1
COMPARATIVE ASSESMENT OF % RELIEF FUNCTIONAL PARAMETERS
| Functional Parameters |
% Relief
|Group A
Group B
Group C
|Grip Strength RH
10.7
15.4
63
|Grip Strength LH
13.3
34.8
51.6
|Foot Pressure RL
75
25.0
100.0
|Foot Pressure LL
78.6
18.2
93.3
|Goniometry
58.1
22.3
78.2
COMPARATIVE ASSESMENT OF % RELIEF ON BIOCHEMICAL PARAMETERS
| Biochemical parameters |
% Relief in
|Group A
Group B
Group C
|Hb
2.7
2.9
2.8
|ESR
41.0
26.7
45.2
|RA Factor
9.0
23.4
41.7
|CRP
19.2
21.2
54.2
ESTIMATION OF OVERALL RESPONSE IN EACH GROUP
| Group A |
Group B
Group C
|No
%
No
%
No
%
|Excellent (> 75%)
1
6.7%
0
0
2
15.4%
|Marked Improvement
(50-74%)
7
46.6%
4
33.4%
8
61.6%
|Mild Improvement (
25-49%)
7
46.6%
7
58.3%
3
23%
|No Improvement (<24%)
0
0
1
8.3%
0
0
DISCUSSION
PROBABLE MODE OF ACTION OF DRUGS
1. HINGWADI CHURNA
The combined action of “Hingwadi Churna†can be summarised as Kapha-Vata Shamak, Agni Deepan , Ama-pachan, Shulahara and Vednasthapana. Thus, the drug was effective in breaking the pathogenesis of Amavata.
2. RASNA –DASHMULA KWATHA
Contents ofRasna-Dashmula Kwatha are mainly Vata –Kaphahar andhave Ama –Pachan, Shulahara, Jwarahara and Vednasthapana properties .Guduchi present in it is a Rasyana and has anti-oxidant and immunomodulator properties. All these actions of Rasna-Dashmula Kwatha resulted in Samprapti Vighatana of Amavata and provided relief in symptoms.
3. SAINDHAVADI TAILA MATRA VASTI
It also contains Vednasthapan dravyas like Rasna, Erand Mula, Renuka Beeja, Nili Vriksha and Mulethi. and Vata –Kaphahar Dravyas like Devadaru, Medaa, Kataphal, Chavya etc. Ama and Vata are the two main pathological factors in Amavata which gets subsided by this. Matra Vasti is a type of Sneha Vasti. It causes nourishment and cures diseases caused by aggravated Vata.
SUMMARY & CONCLUSION
In present study observations were as follows:
· Maximum patients belonged to the age group of 41-50 years (55.6 %)
· Maximum patients were females (93.3%).
· Maximum number of patients belonged to Hindu community (93.3%).
· Maximum patients were married (93.3%).
· Maximum numbers of patients were from urban areas (86.7%)
· Maximum patients had educational qualification up to Matriculate i.e. 35.6 %
· Maximum patients belonged to lower middle class (55.4%)
· Maximum patients were house wives (62.2%).
· Maximum patients had no addiction (77.7%).
· Maximum patients did not exercise at all (65%).
· Maximum patients had sound sleep (55.6%) whereas, 44.4 % patients had disturbed sleep
· Family history was positive in 33.3% patients.
· Maximum patients (55.6%) were of Vata-Kaphaj Prakriti followed by Kapha-Pittaj Prakriti (24.4%)
· Majority of patients were of Madhyama Sara (71.1%),Madhyama samhanana (57.8%) Madhyama Satmya (64.4% Madhyam Satva (71.1%)
· Maximum patients in the present study had Avara Abhyavarana Shakti (62.2%), Avara Jarana Shakti (80.0%) and Avara Vyayama Shakti (66.7%).
· RA Factor was positive in 37.8% patients & CRP was positive in 18 patients.
Results obtained were as follows:-
In Group A (Hingwadi Churna & Rasna Dashmula Kwatha)
· Statistically highly significant result was found in subjective parameters like Pain duration and Sparshasahyata.
· Statistically significant result was found in subjective parameters like Visual Analogue Pain Scale, Pain Intensity, Sandhishotha, Gaurav, Jwara, Aruchi, & Apaka.
· In functional parameters statistically significant result was found in foot pressure & goniometry
· In biochemical parameters statistically highly significant result was found in Erythrocyte sedimentation rate (ESR) & statistically significant result was found in Hb % level.
In Group B (Saindhavadi Taila Matra Vasti)
· Statistically significant result was found in subjective parameters like Pain Intensity, Sandhishotha, Gaurav, Jwara, Aruchi, Apaka & Utsahahani.
· Statistically non- significant result was found in all the functional parameters.
· In biochemical parameters statistically significant result was found in ESR only.
In Group C (Hingwadi Churna, Rasna Dashmula Kwatha & Saindhavadi Taila
Matra Vasti)
· Statistically highly significant result was found in subjective parameters like Visual Analogue Pain Scale, Pain duration and Apaka.
· Statistically significant result was found in rest of the subjective parameters viz. Pain Intensity, Pain frequency, Sandhishotha, Gaurav, Jwara, Aruchi, Sparshasahyata, Jadya, Bahumutrata and Utsahahani.
· Statistically highly significant result was found in grip strength (right hand) whereas statistically significant result was found in rest of the functional parameters viz. grip strength (left hand), foot pressure & goniometry.
· In biochemical parameters statistically highly significant result was found in ESR whereas statistically significant result was found in Hb level and CRP.
Inter Group Comparison
· On Comparative assessment of % relief in Subjective Parameters it was found that patients got better relief in Group C than the other two groups in the majority of sign and symptoms.
· On Comparative assessment of % relief in Functional and Biochemical Parameters it was found that in Group C patients got better relief than the other two groups.
· On inter group comparison by Kruskal Wallis and One Way Anova Tests it was found that group C was Statistically more significant than the other two groups.
· The overall effect of Group C (Hingwadi Churna, Rasna Dashmula Kwatha &
Saindhavadi Taila Matra Vasti) was best followed by Group A (Hingwadi Churna, Rasna Dashmula Kwatha) and Group B (Saindhavadi Taila Matra Vasti).
· 28 patients came for 1st follow up and 15 patients turned up for the 2nd follow up. Recurrence of symptoms was seen after discontinuation of treatment.
CONCLUSION
“Conclusions†drawn from present work are as follows:
v Amavata is a Kapha- Vata Pradhana Tridoshaja Vyadhi which has clinical
features similar to Rheumatoid Arthritis.
v Combined effect of Hingwadi Churna & Rasna*- Dashmula Kwatha* was better than Saindhavadi Taila Matra Vasti.
v Hingwadi Churna, Rasna- Dashmula Kwatha and Saindhvadi Taila, when given together proved quite effective in managing the patients of Amavata.
v As, Hingwadi Churna due to its contents did Agni Deepan and Ama Pachan. Thus, breaking the pathogenesis of Amavata. Rasna- Dashmula Kwatha did Kapha –Vata Shaman and proved very effective in subsiding symptoms like Sandhishula, Sandhishotha, Jwara Jadya etc. Saindhavadi Taila Matra Vasti pacified the aggravated Vata. Thus, it can be considered a complete treatment as it covered all aspects of Amavata Chikitsa Siddhanta*.*
RECOMMENDATION:
· Study should be repeated by taking larger sample with longer duration to see
effectiveness of drugs in managing the disease.
· A study can be conducted to find the individual efficacy of Hingwadi Churna
& Rasna-Dashmula Kwatha.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients having classical features of Amavata.
- •Age group of 18-60 years.
- •Patients fulfilling American College of Rheumatology (ACR) criteria,
- •Both sero -positive and sero- negative cases were included in present study.
排除标准
- •Chronicity for more than 15 years.
- •Patients with other systemic diseases like Cardiac disease, Tuberculosis, Diabetes mellitus, Hypertension.
- •Any other serious medically and surgically ill patients.
结局指标
主要结局
To assess the effect of therapy subjectively and objectively, all
时间窗: 60 days
the signs and symptoms were given scoring
时间窗: 60 days
depending upon their severity.
时间窗: 60 days
The result thus obtained from individual patient was categorized as:
时间窗: 60 days
Excellent ≥75% relief
时间窗: 60 days
Marked Improvement ≥50% up to 74% relief
时间窗: 60 days
Mild improvement ≥25% up to 49% relief
时间窗: 60 days
No improvement ≤24% relief
时间窗: 60 days
次要结局
- Exacerbations in sign and symptoms(1 month)
