A Clinical Study on Arthritis.
- Conditions
- Amavata (Rheumatoid arthritis)
- Registration Number
- CTRI/2017/08/009423
- Lead Sponsor
- Rishikul Campus Haridwar UAU
- Brief Summary
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 Arthritisâ€** is presented under following headings:
1. Introduction
2. Review of Literature
· Ayurvedic Review
· Modern Review
· Drug Review
3. Materials and Methods
4. Observation and Results
5. Discussion
6. Summary and conclusion
7. References
8. 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*** ***M******atra*** ***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¤•à¤°à¤®à¥** **| â€**
**à¤à¤¾à¤—ोतà¥à¤¤à¤°à¤®à¤¿à¤¦à¤‚****चूरà¥à¤£à¤‚****पीतं****वातामजिदà¥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¥‚मà¥** **||** **(****Chakra. Amavata Chi /****5)**
***3. SAINDHAVADI*** ***TAILA***
**सैनà¥à¤§à¤µà¤‚****देवकाषà¥à¤ ञà¥à¤š****वचा****शà¥à¤£à¥à¤ ी****च****कटफलमà¥** **|**
**शताहà¥à¤µà¤¾****मà¥à¤¸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¤•à¤‚****बà¥à¤°à¤¹à¥à¤®à¤¯à¤·à¥à¤Ÿà¤¿à¤•à¤¾** **|**
**शटीविडङà¥à¤—मधà¥à¤•à¤‚****रेणà¥à¤•à¤¾****s****तिविषा****रà¥à¤µà¥** **||**
**अमà¥à¤¬à¤·à¥à¤ ा****नीलिनी****दनà¥à¤¤à¥€à¤®à¥‚लं****मरिचमेव****च** **|**
**अजमोदा****पिपà¥à¤ªà¤²à¥€****च****कà¥à¤·à¥à¤ ं****रासà¥à¤¨à¤¾****च****गà¥à¤°à¤¨à¥à¤¥à¤¿à¤•à¤®à¥** **||**
**à¤à¤·à¤¾****करà¥à¤·à¤®à¤¿à¤¤à¥ˆà¤ƒ****कलà¥à¤•à¥ˆà¤ƒ****शनैरà¥à¤®à¥ƒà¤¦à¥à¤µà¤¿à¤—à¥à¤¨à¤¨à¤¾****पचेतà¥** **|**
**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:
1) To study the aetiopathogenesis of *Amavata*.
2) To assess the efficacy of ***Hingwadi churna*** and ***Rasnadashmulakwatha*** on *Amavata*.
3) To assess the efficacy of ***Saindhavadi Taila Matra Vasti*** on *Amavata*.
4) 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**
1. ***Hingwadi Churna*** - 5 gm b.d. with lukewarm water 1 hour before meal.
2. ***Rasna*** **–*Dashmula* *Kwatha*-** 40 ml b.d. 1 hour after meal.
3. ***Saindhavadi*** ***Taila*** ***M******atra*** ***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*** ***M******atra*** ***Vasti*** alone.
**GROUP C** - Patients were treated with ***Saindhavadi*** ***Taila******M******atra*** ***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)
6.
*Jaadya* (Morning stiffness)
|2.
*Sandhishotha* (Joint swelling)
7.
*Sparshasahyata* (Tenderness)
|3.
*Gaurav* (Heaviness in the body)
8.
*Apaaka* (Indigestion)
|4.
*Jwara* (Fever)
9.
*Bahumutrata* (Frequency of micturition)
|5.
*Aruchi* (Loss of appetite)
10.
*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 of*Rasna*-*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*** ***M******ATRA*** ***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*.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 45
- Patients having classical features of Amavata.
- Age group of 18-60 years.
- Patients fulfilling American College of Rheumatology (ACR) criteria, 1987.
- Both sero -positive and sero- negative cases were included in present study.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the effect of therapy subjectively and objectively, all 60 days the signs and symptoms were given scoring 60 days depending upon their severity. 60 days The result thus obtained from individual patient was categorized as: 60 days Excellent ≥75% relief 60 days Marked Improvement ≥50% up to 74% relief 60 days Mild improvement ≥25% up to 49% relief 60 days No improvement ≤24% relief 60 days
- Secondary Outcome Measures
Name Time Method Exacerbations in sign and symptoms 1 month
Trial Locations
- Locations (1)
Rishikul Campus, Haridwar
🇮🇳Hardwar, UTTARANCHAL, India
Rishikul Campus, Haridwar🇮🇳Hardwar, UTTARANCHAL, IndiaArchana NegiPrincipal investigator8958901101archananegi89@gmail.com