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CTRI Number  CTRI/2023/11/060079 [Registered on: 21/11/2023] Trial Registered Prospectively
Last Modified On: 30/04/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Crossover Trial 
Public Title of Study
Modification(s)  
Study of Moringa leaves and fenugreek seeds for improving bone health  
Scientific Title of Study
Modification(s)  
Effect of Moringa oleifera Leaves and Fenugreek Seeds on Bone Mineral Density in Patients with Osteopenia and Osteoporosis: A Randomized Controlled Trial  
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Swati Khartode 
Designation  Chief Dietician  
Affiliation  Vishwaraj Hospital 
Address  Vishwaraj Hospital, OPD No.-7, Ground floor, Department of Nutrition and Dietetics, Vishwaraj Hospital Loni station, Next to hadapsar, Pune solapur highway- 412201
Vishwaraj Hospital, OPD No.-7, Ground floor, Department of Nutrition and Dietetics, Vishwaraj Hospital Loni station, Next to hadapsar, Pune solapur highway- 412201
Pune
MAHARASHTRA
412201
India 
Phone  9767133699  
Fax    
Email  opd@vrhpune.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Swati Khartode 
Designation  Chief Dietician  
Affiliation  Vishwaraj Hospital 
Address  Vishwaraj Hospital, OPD No.-7, Ground floor, Department of Nutrition and Dietetics, Vishwaraj Hospital Loni station, Next to hadapsar, Pune solapur highway- 412201
Vishwaraj Hospital, OPD No.-7, Ground floor, Department of Nutrition and Dietetics, Vishwaraj Hospital Loni station, Next to hadapsar, Pune solapur highway- 412201

MAHARASHTRA
412201
India 
Phone  9767133699  
Fax    
Email  opd@vrhpune.com  
 
Details of Contact Person
Public Query
 
Name  Dr Swati Khartode 
Designation  Chief Dietician  
Affiliation  Vishwaraj Hospital 
Address  Vishwaraj Hospital, OPD No.-7, Ground floor, Department of Nutrition and Dietetics, Vishwaraj Hospital Loni station, Next to hadapsar, Pune solapur highway- 412201
Vishwaraj Hospital, OPD No.-7, Ground floor, Department of Nutrition and Dietetics, Vishwaraj Hospital Loni station, Next to hadapsar, Pune solapur highway- 412201

MAHARASHTRA
412201
India 
Phone  9767133699  
Fax    
Email  opd@vrhpune.com  
 
Source of Monetary or Material Support  
Vishwaraj Hospital Loni station, Next to hadapsar, Pune solapur highway- 412201  
 
Primary Sponsor  
Name  Vishwaraj Hospital 
Address  Loni Station, Next to hadapsar, Pune-Solapur Highway Pin-412201 
Type of Sponsor  Other [Hospital where prospective study will be done] 
 
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 Swati khartode  Vishwaraj hospital  Vishwaraj Hospital, OPD No.-7, Ground floor, Department of Nutrition and Dietetics, Vishwaraj Hospital Loni station, Next to hadapsar, Pune solapur highway- 412201
Pune
MAHARASHTRA 
9767133699

opd@vrhpune.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee MAEER’s Vishwaraj Hospital Ethics Committee   Approved 
MAEERS Vishwaraj Hospital Ethics Committee  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 
Intervention  Dried moringa leaves for 3 months  Nutritional Intervention of Dried moringa leaves 50 gms for 3 months 
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Confirmed diagnosed Osteopenia patients by DEXA scan (T score -1 to -2.5), male or female patients of 18-60 years. 
 
ExclusionCriteria 
Details  1. Chronic Kidney disease (CKD)
2. Intestinal mal absorption disorders like colitis, IBS etc 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Correction of Osteopenia by including sundried moringa leaves and powder with vitamin d2 rich diet.  3 months 
 
Secondary Outcome  
Outcome  TimePoints 
To check symptomatic relief occurred due to Osteopenia like   3 months 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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 3/ Phase 4 
Date of First Enrollment (India)   01/12/2023 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Osteopenia means abnormal bone density but not as low as osteoporosis. (Karaguzel, G., & Holick, M. F. (2010). It is a condition when bones start to lose mass, also bone mineral density (BMD) measures lower than average, but not as low as in osteoporosis. (TO, O. G. What is osteopenia?).

World Health Organization is defined osteopenia by bone densitometry as a T score −1 to −2.5. There are so many reasons that cause osteopenia including calcium and vitamin D deficiency and inactivity (Karaguzel, G., & Holick, M. F. (2010).

Still, with osteopenia, the bones lose calcium and become porous and weak, making more vulnerable to fractures. Osteopenia does not cause symptoms, but it is a precursor to osteoporosis. While it doesn’t always develop into osteoporosis, it’s important to address osteopenia immediately to prevent further decline in bone mass. (TO, O. G. What is osteopenia?).

Nearly one out of two adults has osteopenia and one out of five adults has osteoporosis. Osteoporosis prevalence was higher in the women and in the elderly. Nearly one out of three women in postmenopausal age group has osteoporosis. Considering the significant prevalence of low BMD, there is a need to increase the awareness about bone health in general population. (Babhulkar, S., & Seth, S. (2021).

Worldwide, it is estimated that 1 in 3 women above the age of 50 will experience osteoporotic fractures, as well as 1 in 5 men.

India with a population of 1.2 billion people is the second most populated country in the world with approximately 10% of population (more than 100 million) over 50 years of age. In 2013, sources estimate that 50 million people in India are either osteoporotic (T-score lower than-2.5) or have low bone mass (T-score between-1.0 and-2.5). Studies indicate that osteoporosis and osteopenia or low bone mass may occur at a relatively younger age in Indian population (Kadam, N. S.,et al. 2018).

Bone is a complex cellular tissue. It contains approximately 70% mineral and 30% organic constituents. The mineral phase consists of about 95% hydroxyapatite, a highly organized crystal of calcium and phosphorous, and other ions (such as sodium, magnesium, fluoride, and strontium). Bone mass and density are determined by various concurrent factors, such as genetics, hormones, physical activity and nutrition. Among the various nutrients, calcium and vitamin D have proven their efficacy for normal bone growth and development in children and adolescents and for the maintenance of bone mineral loss in postmenopausal women. An optimal calcium intake is necessary for bone health at all stages of life. Dietary requirements for calcium are determined by the need for bone development and bone maintenance, which vary throughout life, being higher during childhood and adolescence, during pregnancy and lactation, and in the elderly (Vannucci, L., et al. 2018).

 Moringa oleifera Lam is a multipurpose and exceptionally nutritious vegetable tree with a variety of potential uses and native to Indian subcontinent. Tree occupies important position in the Indian vegetable industry. Almost all parts of the plant contain some remarkable medicinal and pharmaceutical properties and can be consumed for long time. It is used in more than 80 countries to relieve vitamin and mineral deficiencies, beneficial in cardiovascular system, blood-glucose levels, malignancy by neutralizing free radicals, immune system of the body, in mental alertness, improvement in eyesight, general weakness, lactating mothers, menopause, bone strength, and depression. In India, it is grown for its leaves, flowers, and pods. Its pod is a prevalent vegetable in south part of India. The leaves of Moringa tree possess remarkable nutritional and medicinal qualities, they are rich source of minerals and vitamins and exhibits antioxidant activity and phenolic compound like quercetin and kaempferol. Fresh leaves of Moringa are a good source of carotenoids with pro-vitamin A. They contain high amount of vitamin C, vitamin A, Calcium, which builds strong bones and teeth and helps prevent osteoporosis; Potassium and Proteins, the basic building blocks of all our body cells , contains all of the essential amino acids in a good proportion, also contains argenine and histidine  two amino acids especially important for infants, who are unable to make enough protein for their growth requirements.

Different preparation from Moringa leaves, flowers, and fruits are used in Indian subcontinent for various purposes. Due to high nutritional value, it is a popular vital food source against PEM, which is quite common in under developed and developing countries.

The micro-nutrient content is even more in dried leaves. Therefore it is necessary to increase the utilization of Moringa leaves consumption by the different communities. It should be consumed either fresh or dry. Dried leaves can be stored for a long time and can be used regularly.

 Many companies across the world manufacturing various products of Moringa leaves such as Moringa Tea, Moringa Tablets, Moringa Capsules, Moringa leaf Powder, Moringa Soaps and Moringa Face wash. Leaves can be eaten fresh, cooked, or stored as dried powder for many months without refrigeration, and reportedly without loss of nutritional value. Leaves were also used for food fortification Spoonful of the powder can then be added to baby food, soups, and vegetables, adding nutrition but not changing the taste. In this way, Moringa leaves will be ready available to improve nutritional intake on a daily basis (Singh, L., Singh, J., & Singh, J. (2019), (Mishra, S. P., Singh, P., & Singh, S. (2012).

Thus we have seen Moringa leaves are rich in many nutrients, also available round the year at all places in India, so we will use this nutrient dense leaves to osteopenia patients and will check whether its intervention is beneficial effect on osteopenia or not.

 
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