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CTRI Number  CTRI/2020/07/026939 [Registered on: 31/07/2020] Trial Registered Prospectively
Last Modified On: 21/10/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [Panchkarma]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Management of Asthi-Majja-Kshaya w.s.r. to Low Bone Mineral Density in Ayurveda 
Scientific Title of Study   A Comparative Clinical Study to Evaluate the Efficacy of Vrishyamuladi Taila and Shatavari Taila Matra Basti with Vyoshadhya Gutika Guggulu in the Management of Asthi-Majja-Kshaya w.s.r. to Low Bone Mineral Density 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Gopesh Mangal 
Designation  Associate Professor 
Affiliation  NIA Jaipur 
Address  Dept of Panchkarma NIA Jaipur Jorawar Singh Gate Amer road Dept of Panchkarma NIA Jaipur Jorawar Singh Gate Amer road Jaipur RAJASTHAN 302002 India

Jaipur
RAJASTHAN
302002
India 
Phone    
Fax    
Email  gmangal108@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Avvinish Narine 
Designation  MD Scholar 
Affiliation  National Institute of Ayurveda 
Address  Dept of Panchkarma NIA Jaipur Jorawar Singh Gate Amer road Dept of Panchkarma NIA Jaipur Jorawar Singh Gate Amer road Jaipur RAJASTHAN 302002 India

Jaipur
RAJASTHAN
302002
India 
Phone  9971216140  
Fax    
Email  avvinish@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Avvinish Narine 
Designation  MD Scholar 
Affiliation  National Institute of Ayurveda 
Address  Dept of Panchkarma NIA Jaipur Jorawar Singh Gate Amer road Dept of Panchkarma NIA Jaipur Jorawar Singh Gate Amer road Jaipur RAJASTHAN 302002 India

Jaipur
RAJASTHAN
302002
India 
Phone  9971216140  
Fax    
Email  avvinish@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda 
 
Primary Sponsor  
Name  National Institute of Ayurveda 
Address  Madhav Vilas Palace Jorahawar Singh gate Amer road Jaipur 302002 Rajasthan  
Type of Sponsor  Government medical college 
 
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 
Dr Avvinish Narine  National Institute of Ayurveda  OPd room no 2 and IPD of Panchakarma Department , National Institute of Ayurveda, Jaipur 302002, Rajasthan
Jaipur
RAJASTHAN 
9971216140

avvinish@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, National Institute of Ayurveda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M859||Disorder of bone density and structure, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Comparator Agent- Shatavari Taila Matra Basti and Vyoshadhya Gutika Guggulu  Shatavari Taila Matra Basti, followed by Vyoshadhya Gutika Guggulu for 30 days will be administered in 30 patients.  
Intervention  Intervention- Vrishyamuladi Taila Matra Basti and Vyoshadhya Gutika Guggulu  Vrishyamuladi Taila Matra Basti, followed by Vyoshadhya Gutika Guggulu for 30 days will be administered in 30 patients. 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients willing to sign consent form for trial.
Patients of either sex in the age group 30 to 60 years.Patients presenting with classical features of Asthi-Majja-Kshaya.
Patients of Low Bone Mineral Density diagnosed by BMD (Bone Mineral Density) pDEXA test; BMD Score (T Score between -1 to -2.5 SD)
 
 
ExclusionCriteria 
Details  Patient below the age of 30 and above 60 years.
Patient suffering from any systemic disorder like Diabetes Melllitus (uncontrolled), Hypertension (uncontrolled), Endocrinal disorders, Hyperparathyroidism, Paget’s disease, Cushing syndrome, Marfan Syndrome, Thyrotoxicosis, Osteogenesis Imperfecta, Homocystinuria.
Patient suffering from pathological osteoporosis or any neoplasm or osteoporosis related to systemic disorders.
Osteoporosis associated with fracture.
Patients not willing to sign consent form for trial
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in Bone Mineral Density   Baseline (day 0), Day 75 
 
Secondary Outcome  
Outcome  TimePoints 
Relief in pain and other symptoms.   75 days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   03/08/2020 
Date of Study Completion (India) 06/04/2021 
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)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Not yet published 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  


INTRODUCTION

BMD refers to Bone Mineral Density, a measure of bone density, reflecting the strength of bones. It detects osteopenia (mild bone loss) and osteoporosis (more severe bone loss) when performed. It measures bone density or mass compared to a healthy person of the same age and gender. BMD measurements, known as T-scores, determine bone density and reveal whether it is normal, osteopenia (low bone mineral density), or osteoporosis (more severe low bone mineral density).

Low bone mass that isn’t precisely osteoporosis is referred to as osteopenia. It is a condition in which bone mineral density is lower than average. It’s thought to be a precursor to osteoporosis. Osteoporosis is a widespread clinical condition affecting multiple bones in which bone tissue density is reduced quantitatively, resulting in a brittle skeleton.

Osteopenia, often known as low bone mass or low bone mineral density, is an ailment in which the bone mineral density is low. Due to the bone being weaker, it can increase the likelihood of fracture and may lead to osteoporosis later in life.

Osteoporosis is a worldwide public health concern wherein the number of people with osteoporosis and fractures is expected to increase as the number of elderly people in developed and developing countries grows. Strong bones are essential for our health since they play a vital part in the body’s overall function. Moreover, as they provide a frame for the body and protect vital organs such as the heart and other organs, they also offer support and structure.

            Ayurveda is one of the most ancient medical sciences in the world. It conceives and describes the basis & applied aspect of life process, health, disease & its management in terms of its principles & approaches. There is no exact clinical entity mentioned in Ayurvedic classics like low bone mineral density or osteoporosis; however, the bone conditions Asthi-Kshaya and Asthi Saushirya have some clinical resemblance. Asthi-Saushirya is mentioned as a Majja-Kshaya, whereas; Asthi-Kshaya is cited as an independent condition. Asthi-Kshaya is ‘decrease in the bone tissue’ and Asthi-Saushirya means’ porous bones.’ Hemadri has commented on the word ‘Saushirya’ as ‘Sarandhratvam,’ which means ‘with pores.’ This condition is explained in the context of Majja-Kshaya. Asthi, considered as the major seat of Vayu and the condition of Asthi-Majja-Kshaya can lead to aggravated Vata Dosha.

            Acharya Charaka has advocated the use of Snehana for aggravated Vata in Asthi and Majja Dhatu. He has indicated Basti as the Ardhachikitsa for the Vataj disorders and in Asthi-Kshaya. Aggravated Vata Dosha is responsible for the pathogenesis of Asthi-Majja-Kshaya. Considering osteopenia and osteoporosis as a degenerative Vata dominant bone disorder, the present clinical study was planned to evaluate the efficacy of Matra Basti and Shaman Chikitsa mentioned in the treatment of Vatavyadhi. For Matra Basti, two oil-based formulations, viz: Vrishyamuladi Taila and Shatavari Taila, were selected for evaluating the comparative efficacy, whereas, for Shaman, Vyoshadhya Gutika Guggulu was selected as indicated in the treatment of Asthi-Majja-Kshaya.


WORK PLAN

GROUPING: Subjects were randomly divided into two groups:

Group A: 17 Patients in this group were given Vrishyamuladi Taila Matra Basti and Vyoshadhya Gutika Guggulu

Group B: 17 Patients in this group were given Shatavari Taila Matra Basti and Vyoshadhya Gutika Guggulu.

 

ASSESSMENT: On the basis of BMD score and Ayurvedic Parameters, assessment was done before treatment, after treatment and during last follow up.

 

PROCEDURE:

Group A: Patients in this group were given Vrishyamuladi Taila Matra Basti and Vyoshadhya Gutika Guggulu

a. Sthanik Abhyang and Swedan was done for 16 days during the morning period,  before administering Basti.

b. Vrishyamuladi Taila Matra Basti, in the dose of 60 ml, once daily was administered through rectal route as per “Kala Basti” schedule, for 16 days.

c. Vyoshadhya Gutika Guggulu was administered in the dose of 1g twice a day orally with lukewarm water for 30 days, after Basti was completed.

 

Group B: Patients in this group were given Shatavari Taila Matra Basti and Vyoshadhya Gutika Guggulu.

a. Sthanik Abhyang and Swedan was done for 16 days during the morning period, before administering Basti.

b. Shatavari Taila Matra Basti, in the dose of 60ml, once daily was administered through rectal route as per “Kala Basti” schedule, for 16 days.

c. Vyoshadhya Gutika Guggulu was administered in the dose of 1g twice a day orally with lukewarm water for 30 days, after Basti was completed.


Effect of Therapy on Subjective Parameters in Group A:

There was a 41.94% improvement reported in Asthishoola (bone pain), followed by 54.17% improvement in Asthitoda (pricking pain in bone), 50.00% improvement was noted in Nakhabhanga (splitting of nails), 42.86% improvement was noted in Raukshya (dryness), 47.62% improvement was noted in Aswapna (loss of sleep), 52.63% improvement was noted in Satataruka (continuous pain).

 

Effect of Therapy on Subjective Parameters in Group B:

There was a 52.78% improvement reported in Asthishoola (bone pain), followed by 46.88% improvement in Asthitoda (pricking pain in bone), 54.55% improvement was noted in Nakhabhanga (splitting of nails), 50.00% improvement was noted in Raukshya (dryness), 46.43% improvement was noted in Aswapna (loss of sleep), 39.29% improvement was noted in Satataruka (continuous pain).

 

 

Effect of Therapy on Objective Parameters in Group A:

There was a 4.69% improvement observed in Vitamin D3, then 1.06% improvement was observed in Serum Calcium and 1.49% improvement was observed in BMD levels.

 

Effect of Therapy on Objective Parameters in Group B:

There was a 4.43% improvement observed in Vitamin D3, then 1.16% improvement was observed in Serum Calcium and 1.87% improvement was observed in BMD levels.

 

Comparison of Objective Parameters between Group A and Group B

It was observed that there is no significant difference in any of the parameters tested in both the Group A and Group B comparisons.


Conclusion

Ø  It is concluded that there is no difference between the effect of Vrishyamuladi Taila Matra Basti and Shatavari Taila Matra Basti followed by Vyoshadhya Gutika Guggulu in the Management of Asthi-Majja-Kshaya (Low Bone Mineral Density).



 
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