| CTRI Number |
CTRI/2025/08/093052 [Registered on: 14/08/2025] Trial Registered Prospectively |
| Last Modified On: |
19/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To see the effect of kashaya and its modified dosage form i.e. herbal tea of few drugs of Lekhaniya mahakashaya in patients of sthaulya |
|
Scientific Title of Study
|
A comparative pharmaceutico-analytical and pilot study of kashaya and its modified dosage form herbal tea of few drugs of Lekhaniya mahakashaya in the management of sthaulya |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nikita |
| Designation |
MD Scholar Rasa shastra evum bhaishajya kalpana |
| Affiliation |
Institute for Ayurved Studies and Research Shri Krishna AYUSH University |
| Address |
OPD No 58 ground floor Institute for Ayurved Studies and Research Shri Krishna AYUSH University Sector 8 Umri road Kurukshetra Haryana 136118 India
Kurukshetra
HARYANA
136118
India |
| Phone |
9817047247 |
| Fax |
|
| Email |
nikita.yadav182@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Vidushi Tyagi |
| Designation |
Professor and Chairperson, PG Department of Ras shastra evum bhaishajya kalpana |
| Affiliation |
Institute for Ayurved Studies and Research Shri Krishna AYUSH University |
| Address |
Room No 36 ground floor Institute for Ayurved Studies and Research Shri Krishna AYUSH University Sector 8 Umri road Kurukshetra Haryana 136118 India
Kurukshetra
HARYANA
136118
India |
| Phone |
9355021406 |
| Fax |
|
| Email |
drvidushityagi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nikita |
| Designation |
MD Scholar Rasa shastra evum bhaishajya kalpana |
| Affiliation |
Institute for Ayurved Studies and Research Shri Krishna AYUSH University |
| Address |
OPD No 58 ground floor Institute for Ayurved Studies and Research Shri Krishna AYUSH University Sector 8 Umri road Kurukshetra Haryana 136118 India
Kurukshetra
HARYANA
136118
India |
| Phone |
9817047247 |
| Fax |
|
| Email |
nikita.yadav182@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute for Ayurved Studies and Research Shri Krishna AYUSH University Kurukshetra Haryana 136118 India |
|
|
Primary Sponsor
|
| Name |
Institute for Ayurved Studies and Research Shri Krishna AYUSH University |
| Address |
Sector 8 Umri road Kurukshetra Haryana 136118 India |
| Type of Sponsor |
Other [Government Ayurvedic 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 Nikita |
Institute for Ayurved Studies and Research Shri Krishna AYUSH University Kurukshetra |
OPD No 58 Department of Rasa shastra evum Bhaishajya kalpana Institute for Ayurved Studies and Research Sector 8 Umri road Kurukshetra Haryana 136118 India
Kurukshetra
HARYANA |
9817047247
nikita.yadav182@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E669||Obesity, unspecified. Ayurveda Condition: ATISTHAULYAM (KEVALA-KAPHA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Herbal tea of few drugs of lekhaniya mahakshaya, Reference: NA, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 96(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: -Four drugs from lekhaniya mahakshaya are used ie Daruharidra, Vacha, Ativisha, Chirbilva for preparation of herbal tea. This is the modified dosage form of kashaya.In the dosage form column I have not got the needed drop down entry . So i have mentioned it with the most suitable fitted one. | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kashaya of few drugs of lekhaniya mahakshaya, Reference: Charaka samhita , Sutra sthan 4/3, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 96(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: -Four drugs from lekhaniya mahakshaya are used ie Daruharidra, Vacha, Ativisha, Chirbilva for preparation of kashaya kalpana. |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Pateints with age group of 20 to 45 years of both gender.
Patients with BMI ranges between 25-34.9 kg/m2
(Overweight and Class 1 ).
Patients who had obesity associated with pain in weight bearing joints.
Measurement of waist hip ratio- greater than 0.90 (in men) and greater than 0.85 (in women).
Patients who are willing to sign the consent form.
Patients having sign and symptoms of sthaulya.
|
|
| ExclusionCriteria |
| Details |
Obesity secondary to hypothyroidism.
Patients with hypertension, diabetes mellitus, hyperlipidemia or any other endocrinal disorder.
Any serious disorder of the liver, kidneys, heart, lungs or other organs.
Pregnant and lactating women.
Person undergoing treatment for any other serious illness. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.There is successful conversion of kashaya into herbal tea.
2.The herbal tea is more effective than kashaya in reduction of body weight , BMI and Waist- hip ratio. |
1st- 0 day
2nd- 15th day
3rd- 30th day
4th- 45th day
5th- 60th day
6th- 75th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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 2 |
|
Date of First Enrollment (India)
|
01/06/2026 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
In today’s scenario, sedentary lifestyle and unhealthy eating habits, lifestyle disorders like Sthaulya (obesity) are commonly increasing. Sthaulya is a santarpanajanya vyadhi which is described in Astonnidatiya adhyaya charaka samhita. It is characterised by excessive accumulation of Meda (fat) and Mamsa (muscle), leading to impaired body functions. Acharya Charaka has mentioned Lekhaniya Mahakashaya—a group of 10 herbs with Lekhana karma (scraping properties)—useful in managing Sthaulya. Four herbs—Daruharidra, Vacha, Ativisha, and Chirbilva are taken for preparation of kashaya. Present research work contributes to the dose modification of it into herbal tea form. Kashaya is not so easy in administration so the conversion of it into herbal tea will provide easy and anytime in hand consumption. This dosage form has benefits of easy administration and acceptibility. I aim to see whether there is successful conversion of kashaya into herbal tea along same or more level of its efficacy in comparison. |