| CTRI Number |
CTRI/2026/02/103566 [Registered on: 10/02/2026] Trial Registered Prospectively |
| Last Modified On: |
05/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
The study of changes in Teeth, Nails and Hair in women whose period cycle stopped permanently with weakening of bones. |
|
Scientific Title of Study
|
An observational study of structural changes in Danta Nakha Kesha in Menopausal women w.s.r. to Asthi Kshaya |
| 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 Anwaya Govindrao Isal |
| Designation |
PG Scholar |
| Affiliation |
Radhakisan Toshniwal Ayurved Mahavidyalaya Akola |
| Address |
Radhakisan Toshniwal Ayurved Rugnalaya and Anusandhan Kendra Department-Sharir Rachana Room no 6 Floor no 3 Akola
Akola
MAHARASHTRA
444005
India |
| Phone |
7559226677 |
| Fax |
|
| Email |
anuisal22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yogeshwar Nilkanth Deshpande |
| Designation |
HOD Sharir Rachana department |
| Affiliation |
Radhakisan Toshniwal Ayurved Mahavidyalaya Akola |
| Address |
Radhakisan Toshniwal Ayurved Rugnalaya and Anusandhan Kendra Department-Sharir Rachana Room no 6 Floor no 3 Akola
Akola
MAHARASHTRA
444005
India |
| Phone |
7719923259 |
| Fax |
|
| Email |
yogeshwardeshpande@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anwaya Govindrao Isal |
| Designation |
PG Scholar |
| Affiliation |
Radhakisan Toshniwal Ayurved Mahavidyalaya Akola |
| Address |
Radhakisan Toshniwal Ayurved Rugnalaya and Anusandhan Kendra Department-Sharir Rachana Room no 6 Floor no 3 Akola
Akola
MAHARASHTRA
444005
India |
| Phone |
7559226677 |
| Fax |
|
| Email |
anuisal22@gmail.com |
|
|
Source of Monetary or Material Support
|
| Radhakisan Toshniwal Ayurved Rugnalaya and Anusandhan Kendra Akola 444005 Maharashtra |
|
|
Primary Sponsor
|
| Name |
Dr Anwaya Govindrao Isal |
| Address |
Radhakisan Toshniwal Ayurved Rugnalaya and Anusandhan Kendra Kediya plots Jatharpeth Akola 444005 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anwaya Govindrao Isal |
Radhakisan Toshniwal Ayurved Rugnalaya and Anusandhan Kendra Akola |
Department Kayachikitsa Division OPD block Room no 4 Akola
Akola
MAHARASHTRA |
7559226677
anuisal22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Radhakisan Toshniwal Ayurved Mahavidyalaya Akola |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Structural changes in Danta Nakha Kesha in Menopausal women |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
Postmenopausal women aged between 45-55 years.
1.Patients who have attained natural menopause irrespective of no. of pregnancies,
lactation, height, weight, socio-economic status.
2.Known cases of simple systemic disorders affecting bones, teeth, nails, hair
Eg. Osteoporosis, Hypertension, Diabetes Mellitus, Thyroid disorders,etc.
Patients who are willing to participate.
3.Patients who are willing to participate.
4.Patients who gave informed consent.
|
|
| ExclusionCriteria |
| Details |
1.Women with surgical menopause or drug induced menopause.
Eg. Hysterectomy
2.Women on hormone replacement therapy (HRT).
3.Women on Calcium or Vitamin-D supplements.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To observe the structural changes in Danta, Nakha, Kesha in menopausal women and
evaluate their correlation with the signs and symptoms of Asthi Kshaya, as described
in Classical Ayurvedic texts.
|
18 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To identify common clinical signs & symptoms of Asthi Kshaya in menopausal
women.
2.To assess the severity of structural changes in Danta, Nakha, Kesha using a structured
observation grading scale.
3.To provide an Ayurveda based perspective for early detection & possible preventive
care of Asthi Kshaya during menopause.
4.To strengthen the correlation between observable Updhatu changes & Asthi dhatu. |
18 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
20/02/2026 |
| 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="5"
Days="29" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Menopause is a natural and inevitable phase in a woman’s life, marked by hormonal changes, particularly a decline in estrogen levels, which accelerates bone loss and weakens tissues derived from Asthi dhatu. Modern research has established that postmenopausal women are at an increased risk of osteoporosis, brittle nails, hair thinning, and dental problems. According to Ayurveda, Danta (teeth), Nakha (nails), and Kesha (hair) are considered Updhatu or Mala of Asthi dhatu, and structural deterioration in these tissues may indicate Asthi Kshaya (depletion of bone tissue). Assessment of bone health through conventional investigations is often invasive, costly, and inaccessible in resource-limited settings. In contrast, observation of visible structural changes in teeth, nails, and hair is simple, economical, and non-invasive. However, there is limited integrative research correlating these visible changes with the Ayurvedic concept of Asthi Kshaya in menopausal women. This observational study aims to evaluate structural changes in Danta, Nakha, and Kesha among menopausal women and to establish their correlation with Asthi Kshaya. By bridging classical Ayurvedic knowledge with clinical observation and modern understanding, the study seeks to facilitate early detection of bone tissue depletion, promote preventive healthcare strategies, and contribute to improved menopausal health management from an integrative perspective. |