| CTRI Number |
CTRI/2025/02/080525 [Registered on: 13/02/2025] Trial Registered Prospectively |
| Last Modified On: |
08/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Compare the effect of Kunjal Kriya and Vamana Karma in Prameha (Prediabetes). |
|
Scientific Title of Study
|
A Randomized Open Labelled Comparative Clinical Study to assess the effect of Kunjal Kriya and Vamana Karma in Prameha (Prediabetes). |
| 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 Simran Devgan |
| Designation |
PG Scholar |
| Affiliation |
Institute for Ayurved Studies and Research |
| Address |
OPD NO 2 Department of Swasthavritta and Yoga Institute for Ayurved Studies and Research Shri Krishna AYUSH University Umri Road Sector 8 Kurukshetra Haryana 136118 India
Kurukshetra
HARYANA
136118
India |
| Phone |
9034635708 |
| Fax |
|
| Email |
simrandevg9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shital S Mahadik |
| Designation |
Associate Professor Department of Swasthavritta and Yoga |
| Affiliation |
Institute for Ayurved Studies and Research |
| Address |
Room No 64 PG Department of Swasthavritta and Yoga Institute for Ayurved Studies and Research Shri Krishna AYUSH University Umri Road Sector 8 Kurukshetra Haryana 136118 India
Kurukshetra
HARYANA
136118
India |
| Phone |
9518681904 |
| Fax |
|
| Email |
shitalsingla@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Simran Devgan |
| Designation |
PG Scholar |
| Affiliation |
Institute for Ayurved Studies and Research |
| Address |
OPD NO 2 Department of Swasthavritta and Yoga Institute for Ayurved Studies and Research Shri Krishna AYUSH University Umri Road Sector 8 Kurukshetra Haryana 136118 India
Kurukshetra
HARYANA
136118
India |
| Phone |
9034635708 |
| Fax |
|
| Email |
simrandevg9@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute for Ayurved Studies and Research Shri Krishna AYUSH University Umri Road Sector 8 Kurukshetra 136118 Haryana India |
|
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Primary Sponsor
|
| Name |
Institute for Ayurved Studies and Research |
| Address |
Institute for Ayurved Studies and Research Shri Krishna AYUSH University Sector 8 Kurukshetra 136118 Haryana India |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Simran Devgan |
Institute for Ayurved Studies and Research |
OPD NO 2 Department of Swasthavritta and Yoga Institute for Ayurved Studies and Research Shri Krishna AYUSH University Umri Road Sector 8 Kurukshetra Haryana 136118 India
Kurukshetra
HARYANA |
9034635708
simrandevg9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shri krishna AYUSH University IEC |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:R730||Abnormal glucose. Ayurveda Condition: PRAMEHA-PURVARUPAM, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: Kunjal Kriya
Procedure - Stand near a sink, drink at least six glasses of prepared water one after other, as quickly as possible, until it feels that stomach cannot hold any more. When stomach is full, the urge to vomit will occur automatically. Lean forward, keeping the trunk as horizontal as possible. Open the mouth and place the middle and index finger of right hand as far as possible. Gently rub and press the back of the tongue. This should induce the water to gush out from the stomach.
Frequency - Patient will be adviced to perform Kunjal Kriya early in the morning empty stomach daily for 21 days.
Duration - Total Duration of therapy will be 21 days., Ritucarya: N/A, Acara Rasayana:N/A, Other:N/A, Pathya/Apathya:no, Pathya:, Apathya: | | 2 | Intervention Arm | Procedure | - | vamana-karma/ pracCardanam, वमन-कर्म/ प्रच्छर्दनम् | (Procedure Reference: Charak samhita siddhi sthana , Procedure details: Purva Karma - Deepan- Pachana for 5 days( Day 1 - 5), Snehpana with goghrita for 7 days ( Day 6 - 12)
Abhyanga & Bashpasveda on Day 12, 13 & 14
Pradhan Karma - Vamana - Madanphalachurana ( one antarnakhamusti/13.5 gm), Vacha with madhu & saindhawa, mulethi kwath on Day 14
Paschat Karma - Dhumpana on Day 14 & Sansarjana karma from Day 15 to 21
Total duration of this procedure is 21 days.)
|
|
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subject having Prediabetes with HbA1C between 5.7% to 6.4%
Fasting Blood glucose bwtween 100 to 125 mg/dl |
|
| ExclusionCriteria |
| Details |
Patients below the age of 20 years and above the age of 60 years
Patients having Type 1 Diabetes Mellitus or Gestational Diabetes
Patients on steroids or oral hyperglycemic drugs, suffering from accelerated hypertention, congestive cardiac failure, pregnant women, lactating mothers, suffering from any serious condition and unfit for Vamana karma |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| Changes in the Objective parameters of disease like FBS and HbA1c level |
FBS will be assessed and compared
before procedure 0th day
During process 14th day and 21st day
Follow up on 34th day, 47th day and 60th day
HbA1c will be asseseed and compared before treatment on 0th day and after procedure on 60th day |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Change in Subjective parameters - Pipasadhikyata, Ksudadhikya, Svedadhikya, Angagandha, Nidradhikya, Hasta-pada-tala-daha, Kara- pada suptata, Alasya |
It will be assessed & compared on 0th day, 34th day & 60th day |
|
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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/ Phase 3 |
|
Date of First Enrollment (India)
|
15/04/2025 |
| 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)
|
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
|
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Brief Summary
|
Diabetes Mellitus is a metabolic disease characterized by abnormal rise of glucose level in blood due to complete or relative deficiency of insulin and imbalance between protein, carbohydrate and fat metabolism. Sedentary habits (Asyasukham), excessive sleep, meat soup of domestic animals (Gramya), meat soup of aquatic animals (Audka), curd, freshly harvested paddy, products made from jaggery and all kapha -promoting factors are responsible for cause of Prameha.The Hathyoga Pradipika describes a set of six yogic cleansing practices called Shatkarma or Shatkriya. One of them is Dhauti (Kunjal Kriya). The most popular forms of dhauti includes Vaman dhauti also called as Kunjal Kriya. As quoted in Hathyoga Pradipika, Dhauti (Kunjal Kriya) is clearly mentioned in twenty types of Kapha roga. Prameha is caused due to Bahudosha (excessive dosha), Bahudrava Shleshma (kapha with increased liquidity) and Abaddhameda (increased cholesterol or triglycerides) along with an increase of Kleda (excessive fluidity) in the body, all of which belong to kapha substance in body. Hence samshodhana is best option for elimination of doshas, further Vamana is the treatment specifically for the elimination of excessive Kapha and related substances like kleda which are predominately increased in Prameha.
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