| CTRI Number |
CTRI/2026/02/102828 [Registered on: 03/02/2026] Trial Registered Prospectively |
| Last Modified On: |
02/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Managing Osteopenia through Ayurveda: A Clinical Comparison of Two Guggulu Formulations [ swayambhuva guggulu and ekavimshati guggulu ] |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the effect of swayambhuva guggulu and ekavimshati guggulu in the management of osteopenia (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 Anjali Patel |
| Designation |
PG Scholar |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda College and Hospital |
| Address |
Room no.17, PG Department of Kayachikitsa, Sri Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpet, Chennai
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
9084300773 |
| Fax |
|
| Email |
anjalipatel36125@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vipin S G |
| Designation |
Associate Professor |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda College and Hospital |
| Address |
Room no.17, PG Department of Kayachikitsa, Sri Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpet, Chennai
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
8547626217 |
| Fax |
|
| Email |
drvipinsg@sjsach.org.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anjali Patel |
| Designation |
PG Scholar |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda College and Hospital |
| Address |
Room no 17, PG Department of Kayachikitsa, Sri Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpet, Chennai
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
9760878361 |
| Fax |
|
| Email |
anjalipatel36125@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Jayendra Saraswathi Ayurveda College and Hospital |
|
|
Primary Sponsor
|
| Name |
Anjali Patel |
| Address |
Sri Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpet, Chennai
600123 |
| 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 Anjali Patel |
Sri Jayendra Saraswathi Ayurveda College and Hospital |
Nazarathpet, Chennai
Thiruvallur
Tamil Nadu
600123
Thiruvallur
TAMIL NADU |
09760878361
anjalipatel36125@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Sri Jayendra Saraswathi Ayurveda College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M858||Other specified disorders of bonedensity and structure. Ayurveda Condition: ASTHIKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Swayambhuva Guggulu, Reference: Vangasena Samhita, Vatavyadi Chikitsa, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Antarabhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Lukewarm water), Additional Information: -(2) Medicine Name: Ekavimshati Guggulu, Reference: Yogaratnakara, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Antarabhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Lukewarm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients of osteopenia diagnosed by B.M.D test (t- score -1 to -2.5).
Patients willing to sign the informed consent. |
|
| ExclusionCriteria |
| Details |
Patients below the age of 40 years and above the age of 70 years.
Patient pre-diagnosed and under medication for pathological osteopenia and neoplasms of the bone like osteoma and osteosarcoma.
Patients of known case of hyperthyroidism, Liver disease, kidney disease and Tuberculosis of bone.
Pregnant and lactating women. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To increase the Bone Mineral Density (BMD) of the patient up to normal levels |
90 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assessment on subjective parameters of Asthi Kshaya such as:
–Asthi Shoola
–Danta-nakha-kesha shatanam
–Asthi Toda
–Raukshyam |
90 Days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
16/02/2026 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Osteopenia is a condition marked by reduction in bone mineral density and is common among adults above forty years in India. It increases the risk of fractures and may progress to osteoporosis if untreated. In Ayurveda this condition can be correlated with Asthi Kshaya which occurs due to vitiation of Vata Dosha and improper nourishment of Asthi Dhatu. Swayambhuva Guggulu and Ekavimshati Guggulu are classical Ayurvedic formulations indicated in disorders of bone and joints. These formulations possess Agnideepana, Vata Kaphahara, Sandhaniya, Shothahara and Rasayana properties which help in improving digestion metabolism and nourishment of Asthi Dhatu. This study is planned as a comparative clinical trial to evaluate the efficacy of Swayambhuva Guggulu and Ekavimshati Guggulu in the management of osteopenia Asthi Kshaya based on clinical symptoms and bone mineral density parameters. |