FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2017/08/009423 [Registered on: 21/08/2017] Trial Registered Retrospectively
Last Modified On: 18/08/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Clinical Study on Arthritis.  
Scientific Title of Study   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 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Punita Pandey 
Designation  Professor 
Affiliation  Rishikul Campus, Haridwar, UAU 
Address  Gurukul Campus, Haridwar, UAU
Deptt. of Kayachikitsa, Rishikul Campus, Haridwar-249401, UAU
Hardwar
UTTARANCHAL
249401
India 
Phone  9319394485  
Fax    
Email  pandey.punita62@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Archana Negi 
Designation  MD Scholar 
Affiliation  Rishikul Campus, Haridwar, UAU 
Address  Deptt. of Kayachikitsa, Rishikul Campus, Haridwar-249401, UAU

Hardwar
UTTARANCHAL
249401
India 
Phone  8958901101  
Fax    
Email  archananegi89@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Archana Negi 
Designation  MD Scholar 
Affiliation  Rishikul Campus, Haridwar, UAU 
Address  Deptt. of Kayachikitsa, Rishikul Campus, Haridwar-249401, UAU

Hardwar
UTTARANCHAL
249401
India 
Phone  8958901101  
Fax    
Email  archananegi89@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Rishikul Campus Haridwar UAU 
Address  Rishikul Campus, Haridwar,249401, Uttarakhand 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Archana Negi  Rishikul Campus, Haridwar  OPD no. 1 & 2,Department of Kayachikitsa, Rishikul Campus, Haridwar-249401, Uttarakhand
Hardwar
UTTARANCHAL 
8958901101

archananegi89@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Amavata (Rheumatoid arthritis),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  1.Hingwadi Churna 2.Rasna –Dashmula Kwatha 3.Saindhavadi Taila Matra Vasti  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 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  
Intervention  Hingwadi Churna 2.Rasna –Dashmula Kwatha   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. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  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.
 
 
ExclusionCriteria 
Details  Chronicity for more than 15 years.
Having severe crippling deformity.
Patients with other systemic diseases like Cardiac disease, Tuberculosis, Diabetes mellitus, Hypertension.
Any other serious medically and surgically ill patients.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the effect of therapy subjectively and objectively, all
the signs and symptoms were given scoring
depending upon their severity.
The result thus obtained from individual patient was categorized as:
Excellent ≥75% relief
Marked Improvement ≥50% up to 74% relief
Mild improvement ≥25% up to 49% relief
No improvement ≤24% relief

 
60 days 
 
Secondary Outcome  
Outcome  TimePoints 
Exacerbations in sign and symptoms  1 month 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   20/12/2016 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="1"
Days="11" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Article published in IAMJ JOURNAL -Management of Amavata (Rheumatoid Arthritis) by Hingwadi Churna and Rasna Dashmula Kwatha Article published in IJAPR JOURNAL-A CLINICAL STUDY TO EVALUATE THE EFFICACY OF HINGWADI CHURNA AND RASNADASHMULA KWATHA IN AMAVATA W.S.R. RHEUMATOID ARTHRITIS  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

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 Arthritis” 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 Matra Vasti1 were selected to evaluate their role in the management of Amavata.

 

1.  HINGWADI CHURNA

  “ हिंगु चव्यं विडं शुण्ठी कृष्णाजाजी सपौष्करम् | ”

    भागोत्तरमिदं चूर्णं पीतं वातामजिद्भवेत्   ||     (Chakra. Amavata Chi /24)

 

2. RASNA –DASHMULA KWATHA

    â€œ दशमूलामृतैरण्ड-रास्नानागरदारुभिः      |  ”                                                           

      à¤•्वाथो रुवूकतैलेन सामं हन्त्यनिलं गुरूम् ||   (Chakra. Amavata Chi /5)

 

3. SAINDHAVADI TAILA

    सैन्धवं देवकाष्ठञ्च वचा शुण्ठी च कटफलम् |

    शताह्वा मुस्तकं चव्यं मेदे मलहरं त्रिवृत् ||

    हिज्जलस्य त्वचं बालं चित्रकं ब्रह्मयष्टिका |

    शटीविडङ्गमधुकं रेणुकाsतिविषा रुवु ||

    अम्बष्ठा नीलिनी दन्तीमूलं मरिचमेव च |

    अजमोदा पिप्पली च कुष्ठं रास्ना च ग्रन्थिकम् ||

    एषा कर्षमितैः कल्कैः शनैर्मृद्विग्नना पचेत् |

    प्रस्थञ्च कटुतैलस्य मूर्च्छितस्य यथाविधि ||

    एतत्तैलवरं श्रेष्ठमभ्यङ्गात् सर्ववातनुत् |                                                       

    विशेषेणामवातेषु कटीजानूरुसन्धिषु   ||    (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 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.      

 

DRUG 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 Taila Matra 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 and have 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.


 
Close