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CTRI Number  CTRI/2017/01/007742 [Registered on: 25/01/2017] Trial Registered Retrospectively
Last Modified On: 26/03/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of meditation in anidra 
Scientific Title of Study   A critical study on trividha aushadha and applied aspect of ahitebhyo arthebhyo manonigraha in the management of anidra 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  priyanka rawal 
Designation  MD Scholar 
Affiliation  IPGT and RA GAU Jamnagar 
Address  OPD No 18 Department of Basic Principles IPGT and RA GAU Jammagar

Jamnagar
GUJARAT
361008
India 
Phone  8511168165  
Fax    
Email  priyankadrraw@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Mahesh Vyas 
Designation  Professor HOD 
Affiliation  IPGT and RA GAU Jamnagar 
Address  3rd floor Department of Basic Principles IPGT and RA GAU Jammagar GUJARAT INDIA 3rd floor Department of Basic Principles IPGT and RA GAU Jammagar GUJARAT Jamnagar

Jamnagar
GUJARAT
361008
India 
Phone  9426953118  
Fax    
Email  drmaheshvyas@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Prof Mahesh Vyas 
Designation  Professor HOD 
Affiliation  IPGT and RA GAU Jamnagar 
Address  3rd floor Department of Basic Principles IPGT and RA GAU Jammagar GUJARAT INDIA 3rd floor Department of Basic Principles IPGT and RA GAU Jammagar GUJARAT Jamnagar

Jamnagar
GUJARAT
361008
India 
Phone  9426953118  
Fax    
Email  drmaheshvyas@yahoo.com  
 
Source of Monetary or Material Support  
IPGT RA GAU Jamnagar Gujarat India 
 
Primary Sponsor  
Name  IPGT RA GAU Jamnagar Gujarat India 
Address  IPGT RA GAU Jamnagar Gujarat India 361008 
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 
priyanka rawal  OPD No 18 IPGT & RA Hospital GAU Jamnagar  OPD No 18 Department of Basic Principles IPGT RA Hospital Gujarat Ayurved University
Jamnagar
GUJARAT 
8511168165

priyankadrraw@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Anidra,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Guda Pippalimoola Churana   Dose 1 gm two times Route Oral Time of Administration After Meal Anupana Mahishi Kshira  
Intervention  relaxation techniques   1.Shithilikarana Vyayama 3-5 min 2.Surya Namaskara 2 rounds 3. Nadi Shuddhi Pranayama 9rounds 4. Brahmari Pranayama 5rounds 5. Aum chanting 9 times 6. Yoga Nidra 20 min Total duration of treatment 45 min in morning and evening for 28 days  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  a.Patients suffering from sign and symptom of Anidra
b.Patients having age between 20-60 years
c.Primary insomnia like insomnia without identifiable cause
d.Recent change in sleep pattern
e.Patients will be selected without any bar of race religion and sex
 
 
ExclusionCriteria 
Details  Patients having age less than 20 years and more than 60 years
Patients having Anidra due to severe illness like Cardiac diseases Hypertension Diabetes and other chronic disorders etc
Patients with secondary insomnia Alcoholism Exaggeration of previous psychiatric illness (major depression, mania unmada etc)acute systemic pathological conditions like Jwara associated with Anidra Anidra due to severe pain orthopaenia will be excluded from the study
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement will be assessed on the basis of relief found in cardinal symptoms of disease Progress in the signs and symptoms based on the standard pattern will be applied before and after treatment
 
28 days
 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement will be assessed on the basis of relief found in cardinal symptoms of disease Progress in the signs and symptoms based on the standard pattern will be applied before and after treatment  28 days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 1/ Phase 2 
Date of First Enrollment (India)   01/04/2016 
Date of Study Completion (India) 03/02/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   not yet published 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  

·         STUDY DESIGN:-

Design selected for this study is open randomized clinical type.

 

METHOD:

 

Criteria for selection of patients:-

Ø  The patients having sign symptoms of Anidra will be selected irrespective of sex, religion etc. from the O.P.D. and I.P.D. Department of Basic Principles, I.P.G.T. & R.A. Hospital, Gujarat Ayurved University Jamnagar. A special scoring pattern will be developed for assessing signs and symptoms.

 

 Inclusion criteria:-

a.       Patients suffering from sign and symptom of Anidra

b.      Patients having age between 20-60 years

c.       Primary insomnia like insomnia without identifiable cause.

d.      Recent change in sleep pattern

e.       Patients will be selected without any bar of race, religion and sex.

Exclusion criteria

Ø  Patients having age less than 20 years and more than 60 years.

Ø  Patients having Anidra due to severe illness like Cardiac diseases, Hypertension, Diabetes & other chronic disorders etc.

Ø  Patients with secondary insomnia, Alcoholism, Exaggeration of previous psychiatric illness (major depression, mania, unmada etc),acute systemic pathological conditions like Jwara associated with Anidra, Anidra due to severe pain, orthopaenia will be excluded from the study.

Wash Out Period –

                     Patient taking regular or intermittent drug for Anidra and drugs for other indication       with sedative effect will be stopped and the treatment will be started after wash out period of 10 days.

 

Grouping:-

Patients suffering from Anidra will be selected & randomly divided into two groups.

Group A:

Here the patients will be treated with relaxation techniques                            Procedure:                                Brahmari Pranayam(4 rounds)  -   Morning And Night

Relaxation therapy - Morning and Night (before sleep)

 

Group B- Here the patients will be treated with Guda Pippalimoola Churana (Vangsen  Samhita)

Dose - 1 gm, two times

Route- Oral

Time of Administration - After Meal

Anupana- Mahishi Kshira

Time period of study    -28 days

Diet-Special diet and life style chart will be prepared and given to patients.

Follow up study- 28 days follow up

 

 

 

Investigations:-

     The following investigations will be done in all the selected persons to assess their actual status and to rule out any systemic disease.

§  Routine hematological investigations

§  Urine- Routine & Microscopic

Any other special investigations will be done if required 

Summary-

The present research work entitled “A critical study on Trividha Aushadha and applied aspect of Ahitebhayo Arthebhayo Manonigraha in the management of Anidra” was carried out by giving special emphasis on literary research and to highlight the special contributions of the various philosophies in Ayurveda to clarify the concept so that it becomes access to find the concealed conventional knowledge.

The present study was planned with following aims and objectives.

1.      To explain and explore the concept of Trividha Aushadham according to Ayurvedic classics.

2.      To assess the effect of Sattvavajaya Chikitsa in the form of relaxation technique and Guda Pipplimula Churana in the management of Anidra. 

 Outline of the Thesis:

The study is divided into eight sections viz.

1.      Conceptual study

2.      Disease review

3.      Drug review – a. Adravyabhoota Chikitsa

                       b.Dravyabhoota Chikitsa

4.      Pharmacognostical study

5.      Analytical study

6.      Clinical study

7.      Discussion

8.      Conclusion

 

In the introduction the subject has been introduced with its utility and importance. The previous works done are also reported. The relevance and the importance of present study were also specified.

1.      Conceptual Study:

Under literary review the literature relevant to the Concepts of Trividha Aushdha was compiled from various treatises along with their commentaries. Concepts from CharakaSamhita, Sushruta Samhita, Ashtanga Sangraha, Hridaya, Kashyapa Samhita, and their various commentaries and also contemporary Samhitas, Sangraha granthas, Nigantus and their commentaries were compiled and then sorted under the following sections in order to generate the review, so as to fulfill the aims according to the each objective.

·         Concept of Aushadha was studied briefly with its synonyms and classification.

·         Concept of Daivavyapashraya  along with its content like Mantra, Mani, Mangala etc is explained along with its importance.

·         Concept of Yuktivyapashraya with Vayutpati and Nirukti of Yukti is explained along with its importance.

·         Nirukti and Vyutpati of Sattvavajya along with its definition.

·          Concept of Sattvavajaya Chikitsa with brief introduction about the description in Veda, Upanishada and Bhagwat Gita was mentioned.

·         Concept of Hita, Ahita Artha and Manonigraha was explained.

·         Various methods for Manonigraha like Gyana,Vigyana,Dhairya, Smriti,Samadhi, Trivarga Anvekhsahna explained by Acharya Charaka, Acharya Vagbhata and Acharya Sushruta was explained.

·         Applied Aspect of Sattvavajaya Chikitsa in different Disease was mentioned.

·          A effort have been made to Compare of western psychotherapy with Indian psychotherapy i.e. Sattvavajaya.

2.      Disease Review:

The disease undertaken, Anidra was reviewed through various texts of classical and contemporary modern science. The study of the aetio-pathogenesis of the disease Anidra incorporating the reasons to select the disease, its possible causes, its signs and symptoms and an acceptable Samprapti.

3.      Drug Review:

 

Adravayabhoota Chikitsa/ Relaxation Techniques

It includes Relaxation techniques, which evokes relaxation responses in the body and mind help in dissociation of mind from its Ahita Artha that’s why it included in Sattavavajaya Chikitsa.

 Relaxation Techniques selected for the study were:

1.      Shithilikarana Vyayama - (3-5 min)

2.      Surya Namaskara - (2 rounds)

3.      Nadi Shuddhi Pranayama - (9 rounds)

4.      Brahmari Pranayama - (5 rounds)

5.       Aum chanting - (9 times)

6.       Yoga Nidra - (20 min)

 

Time: Morning total duration: 40 minutes and 20 min Yoga Nidra at night also.

 

Dravayabhoota Chikitsa  

Pippalimula powder has Vatahara property and thus is able to break the pathogenesis of Anidra at different levels. 1gm of Pippalimula is given to patient with Guda and Anupana of Mahishi Ksheera twice a Day.

 

4.Pharmacognostical Study:

In this study, organoleptic characters, macroscopic feature and microscopic characteristics of Pippalimula have been studied for authentication.

5.Analytical Study:

In this study, Drugs were analyzed with appropriate protocols for standard physico-chemical parameters, Qualitative analysis.

6. Clinical Study:

In clinical study section aims and objectives of the applied clinical study, patients and methodology, criteria for selection and assessment of the patients, divisions of groups and drug administration there in etc. were mentioned.

The study was conducted to assess the effect of Sattvavajya Chikitsa in the form of relaxation techniques and Guda Pippalimula Churana in the management of Anidra. Total 64 patient were registered for study out of them 33 in group A and 31 in group B. 3 Patient were dropped out from group A and one from group B .The patients selected for the study were randomly divided into 2 groups viz. as shown in below table.

Table showing grouping for clinical study

Group A

Group B

Relaxation techniques

Pippalimula Churana

Shithilikarana Vyayama    -      (3-5 min)

2 gm in two divided doses

Surya Namaskara              -       (2 rounds)

Nadi Shuddhi Pranayama -       (9 rounds)

Adhobhakta kala

Brahmari Pranayama      -        (5 rounds)

Anupana- Mahishi Kshira and 5 gm Guda

Aum chanting                   -         (9 times)

Study time- 28 days

 

Follow up -28 days

Yoga Nidra                      –         ( 20 min)

Total time – 40 min in morning and 20 min Yoga Nidra  at night also

 

 

Assessment of the effect of treatment was done on the basis of the relief in the clinical signs and symptoms of the disease as well as improvement present in the subjective criteria.

7.      Discussion:

In this part the discussion regarding every chapter of the conceptual study was critically analysed.  Findings observed in Pharmacognostical study, analytical study and clinical study was discussed. The effect of therapy on the symptoms was discussed logically.

 

8.      Conclusion:

Ø  In both the groups A and B no patients got cured completely. Marked improvement in Group A and Group B was 80 % and 63.33 % respectively. Moderate improvement observed in Group A was 20% and in Group B was 36.66%. 


 
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