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Management of Asthi-Majja-Kshaya w.s.r. to Low Bone Mineral Density in Ayurveda

Phase 2
Completed
Conditions
Disorder of bone density and structure, unspecified,
Registration Number
CTRI/2020/07/026939
Lead Sponsor
National Institute of Ayurveda
Brief Summary

**INTRODUCTION**

BMD refers to Bone Mineral Density, a measure of [bone density](https://www.medicinenet.com/script/main/art.asp?articlekey=2501), reflecting the strength of bones. It detects osteopenia (mild bone loss) and [osteoporosis](https://www.medicinenet.com/osteoporosis/article.htm) (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 Calciumand 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 Calciumand 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).**

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
40
Inclusion Criteria
  • 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).
Exclusion Criteria
  • 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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Improvement in Bone Mineral DensityBaseline (day 0), Day 75
Secondary Outcome Measures
NameTimeMethod
Relief in pain and other symptoms.75 days

Trial Locations

Locations (1)

National Institute of Ayurveda

🇮🇳

Jaipur, RAJASTHAN, India

National Institute of Ayurveda
🇮🇳Jaipur, RAJASTHAN, India
Dr Avvinish Narine
Principal investigator
9971216140
avvinish@gmail.com

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