| CTRI Number |
CTRI/2025/07/091740 [Registered on: 25/07/2025] Trial Registered Prospectively |
| Last Modified On: |
09/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study comparing two ayurvedic medicines for fatty lumps under the skin |
|
Scientific Title of Study
|
A Comparative clinical study of Navak guggulu and Shakhotak Kwath in Medoja Granthi (Lipoma) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sonali |
| Designation |
Pg scholar |
| Affiliation |
PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN, HARIDWAR |
| Address |
PG DEPARTMENT OF SHALYA TANTRA ,OPD NO-15 PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN, HARIDWAR
PG DEPARTMENT OF SHALYA TANTRA ,OPD NO-15 PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN, HARIDWAR
Hardwar
UTTARANCHAL
249405
India |
| Phone |
8191030497 |
| Fax |
|
| Email |
sonalibhatt93330@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SACHIN GUPTA |
| Designation |
PROFESSOR |
| Affiliation |
PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN |
| Address |
SHALYA TANTRA DEPATMENT ,OPD NO-15,PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN ,HARIDWAR
SHALYA TANTRA DEPATMENT ,OPD NO-15,PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN ,HARIDWAR
Hardwar
UTTARANCHAL
249404
India |
| Phone |
9419135050 |
| Fax |
|
| Email |
chintu.925@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sonali |
| Designation |
Pg scholar |
| Affiliation |
PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN |
| Address |
PG DEPARTMENT OF SHALYA TANTRA ,OPD NO-15 PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN, HARIDWAR
PG DEPARTMENT OF SHALYA TANTRA ,OPD NO-15 PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN, HARIDWAR
Hardwar
UTTARANCHAL
249405
India |
| Phone |
8191030497 |
| Fax |
|
| Email |
sonalibhatt93330@gmail.com |
|
|
Source of Monetary or Material Support
|
| PATANJALI AYURVEDIC HOSPITAL HARIDWAR |
|
|
Primary Sponsor
|
| Name |
PATANJALI AYURVEDIC COLLEGE,HARIDWAR |
| Address |
PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN, HARIDWAR |
| Type of Sponsor |
Private medical college |
|
|
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 Sonali MD first year |
PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN, HARIDWAR |
OPD NO. 15 SHALYA TANTRA , PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN, HARIDWAR
Hardwar
UTTARANCHAL |
8191030497
sonalibhatt93330@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE,PATANJALI AYURVEDIC COLLEGE ,HARIDWAR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:D173||Benign lipomatous neoplasm of skinand subcutaneous tissue of other and unspecified sites. Ayurveda Condition: MEDOJAGRANTHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: shakhotak kwath, Reference: Sharangdhar samhita, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: shakhotak kwath, Reference: Sharangdhar samhita , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -luke warm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
patient willing for the consent.
patient of age between 18 to 70 years of both sexes.
patient having lipoma anywhere on the body. |
|
| ExclusionCriteria |
| Details |
patient having lipoma with inflammation and hyperpigmentation.
Infected lipoma.
Calcified lipoma.
Ulcerated lipoma.
malignant changes in liopma[liposarcoma]
pregnant women and lactating mothers.
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
SUBJECTIVE PARAMETER-
PAIN SITE |
30 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
OBJECTIVE PARAMETER-
SIZE,NO. . |
30 DAYS |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
06/08/2025 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sonalibhatt93330@gmail.com].
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
IN THIS TRIAL WE ARE SELECTING PATIENTS OF MEDOJ GRANTHI[LIPOMA] AND DIVIDED IN TWO GROUPS [30 PATIENTS IN EACH GROUP].IN 1ST GROUP WE WILL DO INTERVENTION WITH NAVAK GUGGULU .IN 2ND GROUP WE WILL DO INTERVENTION WITH SHAKHOTAK KWATH. COMPERATIVE STUDY TO BE DONE ON THE BASES OF ASSESSMENT BASED ON SUBJECTIVE AND OBJECTIVE PARAMETERS AND INVESTIGATION DURING PRETREATMENT AS DISSCUSSED EARLIER. |