Osteoporosis is the second most common metabolic bone disorder in India, next only to Vitamin D deficiency and certain renal bone diseases (Johnell and Kanis, 2006).  It affects millions of middle-aged and elderly individuals, often reducing mobility, independence and overall quality of life. Worldwide, osteoporosis leads to nearly 8.5 million fractures each year-meaning that an osteoporotic fracture occurs roughly every three seconds (NIAMS, 2023).

In women, bone strength builds steadily from puberty until about 30 years of age, supported by regular physical activity and a diet rich in calcium and vitamin D. However, around the mid-thirties, bone density gradually begins to decline and this process speeds up after menopause due to hormonal changes. As a result, women face nearly a 50% lifetime risk of fragility fractures. To counter this, modern medicine emphasizes preventive care: balanced nutrition, adequate sunlight exposure, calcium and vitamin D supplementation, weight-bearing exercise, routine bone health screening and medications that help regulate bone turnover (Ross et al., 2011). There are several studies claiming effective management of osteoporosis (Awasthi et al., 2024; Reddy and Udupa, 2003; Munshi and Varthakavi, 2019) Among these, calcium remains central especially for postmenopausal women and the elderly since sufficient intake may help slow bone loss. (Shah, 2015).

Calcium supplementation continues to generate debate, despite its importance.  Research shows both benefits and potential risks and the ideal dosage is still not clearly defined. Differences in study design, population characteristics, supplement types and dosages may explain the conflicting findings (Shah, 2015). Some evidence even suggests that dietary calcium might be safer or more effective than supplemental forms. Clearly, more research is needed to better understand how calcium works in the body and how it can be used most safely and effectively.

In recent years plant- based formulations have been gaining popularity and proving to be complementary functional foods, much like those offered by traditional Ayurveda texts (Prasanna et al., 2025). They describe several everyday foods as naturally nourishing and supportive of tissue health. Of which Wheat (Godhum), for example, is mentioned in Yogratnakara (Sasthri, 2017) as beneficial in fracture management, particularly when taken with honey or combined with Laksha and Arjuna along with milk. Wheat is described as strengthening, stabilizing, nourishing and supportive of tissue repair. As a widely accepted staple food, it is considered wholesome and sustaining, with properties that may promote bone health.

This study explores bone mineral density (BMD) in women aged 40-60 years and assess their overall bone health, including traditional indicators of strong bone tissue (Asthi Sarata Lakshanas). The goal is to develop a wheat-based dietary calcium supplement tailored to meet daily calcium needs and help reduce bone loss in older women. Such an approach may provide a safer, more affordable alternative to commercial calcium supplements while reconnecting modern healthcare with time-honored nutritional wisdom.

Study design
 
This study employed a prospective open labelled randomized controlled design for which CONSORT guidelines have been used (Fig 1 Study Flow Diagram), focusing on individuals presented with low Bone Mineral Density (BMD) and symptomatic indications of bone loss, characterized as Symptoms of bone degeneration. The investigation was carried out at Sumatibhai Shah Ayurved Mahavidyalaya, Hadapsar, Pune -28 an urban private hospital and research centre situated in Pune, Maharashtra in academic year 2021-2022. The research period includes various steps like drug authentication, trial drug standardization and analysis, dose preparation, Pre assessment, enrolment, drug distribution, periodic follow ups and post assessment of Participants at the end of study.



Participants were aged between 40 to 60 years with BMD (right heel) falling within the range of 1 to 2.5 standard deviations below the mean, as measured using a portable Calscan device (CM 300 Ultrasound Bone Densitometer) were assessed for bone health using a carefully designed and validated questionnaire. Subsequently, eligible individuals were enlisted and equally randomized into distinct study groups. Initial BMD measurements were recorded and subsequent assessments were conducted on the 60^th day of the intervention. Concurrently, evaluations of bone health were performed at intervals spanning 0, 15, 30, 45 and 60 days within both intervention and control groups.
 
Randomization
 
A cohort of 150 female participants aged 40 to 60 years, regardless of religious, marital, occupational, or socio-economic conditions, were pre-screened for eligibility based on study criteria. Anticipating a 20% attrition rate, 86 eligible subjects were retained for inclusion. Subsequently, these subjects were equally randomized into either the intervention (43 participants) or control group (43 participants). Randomization was adapted through a lottery method without replacement. The process of allocation concealment involved sequentially numbered opaque and sealed envelopes entrusted to an investigator not directly engaged in the study’s implementation.

Blinding: This was an open-label trial; neither participants nor investigators were blinded to group allocation.
 
Sample size calculation
 
The sample size was estimated assuming a 20% difference in BMD improvement, 80% power, 5% significance level, accounting for a 20% dropout rate.
 
Inclusion criteria
 
1. Age: Between 40 to 60 years.
2. Gender: Female
3. Bone Mineral Density: Falling within 1 to 2.5 standard deviations below the mean of young adults.
 
Exclusion criteria
 
Participants presenting the following attributes were excluded from the study:
1. Known cases of hypertension or cardiovascular diseases.
2. Individuals with compromised endocrine function such as hyperthyroidism or parathyroidism.
3. Subjects with documented cases of irritable bowel syndrome, gluten intolerance, or other gastrointestinal absorption disorders.
4. Participants with a history of prolonged corticosteroid therapy.
5. Individuals with a prior history of one or more fractures stemming from falls or minor impacts.
 
Intervention
 
Participants in the experimental group were administered Wheat extract, coupled with a regimen of dietary and lifestyle modifications. On the other hand, subjects in the control group received a calcium supplement integrated with dietary and lifestyle adjustments over the course of 60 days.
 
Wheat extract as intervention
 
Wheat powder (Godhum Churna) in the treatment of fractures (Asthibhagna Chikitsa)
 
Prominent Ayurvedic texts, including Charaka Samhita, Sushruta Samhita, Ashtanga Hridaya, Ashtanga Sangraha, Bhavaprakasha Nighantu, Madanapala Nighantu and Shaligram Nighantu, emphasize the tissue binding “Sandhaniya” quality of Wheat. Acharya Yogratnakara and Chakradatta expound on the utilization of Wheat powder in the treatment of fractures (Asthibhagna Chikitsa). (Sasthri,  2017).
 
Similarity between wheat and bone tissue
 
The human bone’s anatomical composition consists of periosteum (outermost layer), osteons housing Haversian systems, compact bone, cancellous bone forming a mesh-like structure and finally the medullary cavity. Analogously, wheat features a rigid pericarp, seed coats, starchy endosperm arranged from outer to inner layers. Drawing parallels, the outer layers of wheat can be compared to the periosteum, while the starchy endosperm mirrors cancellous bone. Ayurvedically, substances with “Pathya” attributes possess the capacity to augment a tissue (Dhatu) structurally resembling each other. (Trikamaji J, editor. Charaka Samhita of Charaka and Dridhabala, with Ayurveda Dipika commentary, Reprint ed.; 2011). Acharyas advocate the properties of tissue binding (Asthisandhan), unctuousness (Snigdha), augmentation (Bruhana) and strengthening (Balya) for Wheat. According to Chakarapanidatta, tissue binding is a characteristic of a substance that fosters restoration. Therefore, Wheat emerges as an auspicious candidate for bolstering bone health, encompassing both structural and functional facets. (Trikamaji, 2011).
 
Selection of Khapali godhum for intervention
 
In this study, Triticum dicoccum (Khapali Godhum) is employed, resembling the Nandimukhi variety in appearance and qualities endorsed as Wholesome (Pathyakara) by Bhavaprakasha Nighantu, Kaiyadeva Nighantu and Madanapala Nighantu. Triticum dicoccum is a traditional species of wheat distinguished by its desirable texture, enhanced taste and elevated nutritional content. It serves as a robust source of dietary fibers, proteins and carbohydrates, containing total carbohydrate content ranging from 78.7% to 83.2%.
 
Classical Reference to wheat in powder in the treatment of fractures
 
Acharya Yogratnakara significantly explained the utilization of wheat powder as a therapeutic agent in the context of fracture treatment (Sasthri, 2017).
 
Selection of extract form (Satva kalpana)
 
The Triticum dicoccum exhibited an appropriate overall carbohydrate content for the preparation of Extract, a process generally applied to herbs with higher starch content. This approach significantly enhances the therapeutic efficiency of the substance, reduces the therapeutic dosage required, prolongs the drug’s shelf life and introduces a novel perspective on employing dietary substances as medicinal agents. In the present study, the Bhavaprakasha-prescribed method for Guduchi Satva Nirman Vidhi was followed as per guideline for the preparation of Wheat extract, as no definitive classical method for preparing Wheat extract was available.
 
Classical concept of Sandhana
 
Acharya Chakrapani Datta describes tissue binding as preventing loss and promoting storage.

It is conducive to joining and healing. Dalhanacharya and Acharya Vagbhata highlight that substances aiding in bone healing are Sandhaniya. Evidently, Sandhaniya implies “that which heals fractures.” (Trikamaji, 2011). These attributes align with the restoration and prevention of tissue depletion (Dhatu Kshaya), which is pivotal in countering bone degeneration.
 
Probable mode of action of Godhuma satva
 
In cases of exacerbated Vata due to factors causing tissue depletion (Dhatukshaya), Vata tends to occupy vacant cell pores (Strotas), exacerbating the condition.

Wheat’s sweet taste (Madhura Rasa), unctuousness (Snigdha), strengthening quality (Balya Guna) and post-digestive effect (Madhura Vipaka) might counterbalance this aggravated Vata, rectifying osteoporosis (Trikamaji, 2011).

Acharya Kashyapa’s assertion aligns, as balanced Doshas foster Dhatu nourishment.

Wheat extract’s potential action involves mitigating excessive bone resorption through Vata pacification and addressing calcium and vitamin D requirements.
 
Outcome measures
 
Primary outcome - Change in Bone Mineral Density (BMD) at 60 days.
Secondary outcome - Change in bone degeneration (Asthikshaya Lakshana) questionnaire scores at 15, 30, 45 and 60 days.
 
Statistical analysis
 
The data generated from the study was subjected to statistical analysis Performed using SPSS Version 20.0. Missing data handled by excluding incomplete records, categorized into two distinct segments:
1. Analysis of demographic data of study subjects.
2. Analysis of assessment parameters.
 
I. Objective criteria
 
1. Paired t-test: To assess the efficacy within both Group A and Group B.
2. Unpaired t-test: To ascertain the mean differences and establish efficacy comparisons between the two groups.
 
II. Subjective criteria
 
1. Wilcoxon signed rank test: Utilized to assess efficacy within Group A and Group B.
2. Mann whitney U test: To facilitating the determination of significance and comparison between Group A and Group B.

Age wise distribution
 
Among the 70 participants analysed in the study, the age wise distribution revealed the following pattern:

The highest number of subjects (12.85%) were aged 45 years, following this, 8.57% of participants were 48 years old. Age groups 40, 44, 47 and 52 each consisted of 7.14% of the participants. Likewise, age groups 42, 43, 53, 56 each comprised 5.71% of the subjects. There were two subjects (2.85%) in each of the age groups: 49, 50, 51, 54, 57 and 59. Age groups 46, 55 and 60 each included one subject (1.42%).
 
Occupation-wise distribution
 
The distribution based on occupation revealed the following breakdown:

Homemakers constituted the largest proportion, accounting for 46.71% (33) of the participants. Following homemakers, service women constituted 22.85% (16) of the subjects. Staff nurses constituted 12.85% (9) of the participants. Teachers accounted for 7.14% (5) of the subjects. House cleaners comprised 5.71% (3) of the participants. Housekeepers made up 2.85% (2) of the subjects. Pharmacists and data operators each represented 1.42% (1) of the participants.
 
Observations and results of objective criteria (BMD)
 
The Bone Mineral Density (BMD) scores for both Group A (Control) and Group B (Trial) were analysed and the results are presented in the Table 1. Both groups showed improvement in Bone Mineral Density (BMD) after the study. However, the Control Group (Group A) had a greater increase (28.14%) compared to the Trial Group (Group B), which showed a 10.81% increase. This means Group A experienced a larger improvement in BMD than Group B. The t-value and p-value confirm that these results were statistically significant. Confidence Intervals: For the trial group, the mean BMD change was -0.51 (95% CI: -0.63 to -0.39), p = 0.032.



Table 2 Gives a closer analysis reveals that the mean difference in Group A is notably greater than that in Group B. This leads to the conclusion that the observed effect in the control Group (Group A) is superior to that of the Trial Group (Group B). The statistical values of t-Value and P-Value further support the significance of these findings.

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Observations and results of subjective criteria (Questionnaire)
 
From the data presented in Table 3, it can be deduced that within the 10 variables assessed during the study, the Trial Group B exhibited a higher percentage of efficacy in seven variables compared to the Control Group A. Notably, several of these variables were related to bone tissue byproducts (Asthi Mala). Consequently, it can be further inferred that Wheat extract is not only particularly useful for enhancing Bone Mineral Density but also for enhancing the overall health of bone tissue (Asthi Dhatu) and it’s associated by products (Malas).

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Furthermore, the reduction in skin dryness during the trial is noteworthy, considering that dryness is often associated with imbalanced Vata Dosha. This implies that Wheat extract potentially mitigates Vata Dosha.

Collectively, the comprehensive observations above lead to the compelling conclusion that Wheat extract functions statistically significant not only as a calcium supplement but also as a preventive measure against osteoporosis.

From the Table 4, it is evident that the P-Values for nearly all parameters are greater than 0.05. Consequently, the conclusion can be drawn that there is no significant difference between Group A and Group B.

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Moreover, the inference can be made that Wheat extract is as statistically significant as Calcium Supplementation, in terms of objective parameters such as BMD, also across the range of subjective parameters related to bone degeneration. These results indicate that Wheat extract exhibits efficacy in promoting bone health and overall wellness.

Osteoporosis is ‘the silent thief’ and progressive skeletal disease, as it often remains asymptomatic until fractures occur. Women are particularly susceptible, experiencing bone loss at an accelerated rate compared to men. As women over 50 years of age face a higher risk of osteoporosis-related fractures, preventive measures are crucial. This study aimed to examine the effects of Wheat extract in preventing osteoporosis compared to traditional calcium supplementation.

Calcium is known for its role in maintaining bone density, yet it carries potential drawbacks such as kidney stone formation and unsuitability for hypertensive patients. Additionally, recommendations for calcium intake vary, making it challenging to determine optimal daily doses. In contrast, Wheat extract, prepared from a widely consumed staple food, presents an attractive alternative. Its mention in classical texts, like Acharya Yogaratnakara’s reference to Wheat powder in treatment of fractures adds to its suitability as an intervention.

The study enrolled 85 subjects, with 70 subjects meeting the inclusion criteria for BMD assessment using the Calscan device (CM-300 Ultrasound Bone Densitometer). Bone mineral density (BMD) measurements of the right calcaneus were recorded for all participants, who were subsequently allocated into two study groups according to the predefined study protocol. The experimental group received wheat extract in capsule form along with diet and lifestyle modifications, while the control group received conventional calcium supplementation (Shelcal) along with the same diet and lifestyle modifications. Calcium supplementation was administered at 500 mg as per the RDA, while wheat extract was given at 1000 mg (2 capsules of 500 mg each) according to the Sattva Kalpana dosage recommendations.

Though no significant BMD differences emerged between the two groups, the trial group exhibited improvements in overall bone health and showed greater effectiveness in terms of percentiles compared to the control group. This suggests that Wheat extract holds potential effect for osteoporosis prevention.

This study opens path for viewing dietary substances as principal medicines in tackling prevalent public health concerns like osteoporosis. It also advocates for the cultivation of ancient, nutrient-rich varieties of dietary ingredients.
 
Strengths and limitations of the study
 
A notable strength of the study was the use of a dietary supplement that offered an affordable and acceptable means of meeting daily calcium needs. No adverse events were reported and positive changes were observed in bone health among the trial group. However, the absorption of calcium is influenced by various factors that cannot be controlled. This study was limited for universality due to its open-label design, small sample size, single-centre setting and short intervention duration of 60 days.
 
Future directions
 
While the study’s sample size was limited, its intriguing results permits larger studies with longer duration’s to comprehensively analyse Wheat extract’s effects on bone health and overall wellness. Exploring different dosages, preparation methods and timing Wheat extract consumption could provide further insights. Investigating the impact of Wheat varieties on bone health also presents an interesting avenue for research. Wheat extract can be used in food fortification as a plant-based calcium supplement to enhance the nutritional value of various food products specifically for vegetarian populations.

1. This study highlighted the prevalence of osteopenia and osteoporosis among women aged 40 to 60.
2. It has been demonstrated that analysed Wheat extract can be significant choice to calcium supplementation for preventing osteoporosis, particularly in terms of Bone Mineral Density.
3. The trial group exhibited not only improved BMD but also positive changes in subjective parameters like fatigue, heel pain, hair fall, nail brittleness, dental ache, teeth brittleness and skin dryness.
4. Overall, this study suggests that analyse Wheat extract has the potential to be a valuable intervention for osteoporosis prevention and overall bone health enhancement.

The present study was supported by Mr. Khandagale S. for all the help provided in statistical analysis. We are also grateful to the subjects who participated in the study. SSAM Hadapsar, Pune -28 - for library and resources facility.
 
Author contribution statement  
 
Sarita M.: Conceptualization, Methodology, Formal analysis, Investigation, Resources, Data curation, Validation, Writing - original draft, Visualization. Nitesh J.: Conceptualization, Methodology, Writing - review and editing, Supervision.
 
Use of AI
 
Artificial intelligence tools were employed to support grammar correction and improve the linguistic clarity and coherence of the manuscript.
 
Disclaimers
 
The views and conclusions expressed in this article are solely those of the authors and do not necessarily represent the views of their affiliated institutions. The authors are responsible for the accuracy and completeness of the information provided, but do not accept any liability for any direct or indirect losses resulting from the use of this content.
 
Informed consent
 
This study was approved by the institutional Ethical board (Ref: MUHS/E-3/31/) of Sumatibhai Shah Ayurved Mahavidyalaya, Hadapsar, Pune -28 and registered on the clinical trial registry. CTRI/2021/07/035205. Written Informed consent was obtained from all the patients before commencement of the intervention.
 

The authors declare that there are no conflicts of interest regarding the publication of this article. No funding or sponsorship influenced the design of the study, data collection, analysis, decision to publish, or preparation of the manuscript.