| CTRI Number |
CTRI/2025/01/079474 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
24/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Panchakarma Procedure (Basti Karma) And Ayurvedic Medicine (Lipistab Tablet) In The Management Of Medovaha Sroto Dushti W.S.R To Hyperlipidemia. |
|
Scientific Title of Study
|
A Comparative Clinical Study To Evaluate The Efficacy Of Lipistab Tablet (Kalpit Yog) With Or Without Lekhniya Basti In The Management Of Medovaha Sroto Dushti W.S.R To Hyperlipidemia. |
| 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 Paramvir Singh |
| Designation |
PG Scholar |
| Affiliation |
Dayanand Ayurvedic College |
| Address |
Department Of Panchakarma, Dayanand Ayurvedic College,
Mahatma Hansraj Marg, Jalandhar (Punjab), Pin Code- 144008, India
Jalandhar
PUNJAB
144008
India |
| Phone |
9056712507 |
| Fax |
|
| Email |
PARAMVIR1432@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Parveen Kumar |
| Designation |
Associate Professor |
| Affiliation |
Dayanand Ayurvedic College |
| Address |
Department Of Panchakarma, Dayanand Ayurvedic College,
Mahatma Hansraj Marg, Jalandhar (Punjab), Pin Code- 144008, India
Jalandhar
PUNJAB
144008
India |
| Phone |
7589303536 |
| Fax |
|
| Email |
drparv1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Paramvir Singh |
| Designation |
PG Scholar |
| Affiliation |
Dayanand Ayurvedic College |
| Address |
Department Of Panchakarma, Dayanand Ayurvedic College,
Mahatma Hansraj Marg, Jalandhar (Punjab), Pin Code- 144008, India
Jalandhar
PUNJAB
144008
India |
| Phone |
9056712507 |
| Fax |
|
| Email |
PARAMVIR1432@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
| Dayanand Ayurvedic College, Mahatma Hansraj Marg, Jalandhar (Pb), Pin Code- 144008, India |
|
|
Primary Sponsor
|
| Name |
Dayanand Ayurvedic College |
| Address |
Department Of Panchakarma, Dayanand Ayurvedic College,
Mahatma Hansraj Marg, Jalandhar (Punjab), Pin
Code- 144008, India |
| 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 Paramvir Singh |
Dayanand Ayurvedic College, Jalandhar |
Department Of Panchakarma, Dayanand Ayurvedic College,
Mahatma Hansraj Marg, Jalandhar (Punjab), Pin Code- 144008, India
Jalandhar
PUNJAB |
9056712507
PARAMVIR1432@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DAC Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E782||Mixed hyperlipidemia. Ayurveda Condition: MEDOVAHASROTODUSHTIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | bastikarma/vastikarma, बसà¥à¤¤à¤¿à¤•à¤°à¥à¤®/वसà¥à¤¤à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Sushrut Sahimta, Chikitsa Sthan 38/82, Procedure details: Basti Karma: Basti will be administered as per the method mentioned in the text.
Poorva Karma:
First of all, the patient will be subjected to Sathanik Abyanga and Swedan karma on empty stomach. However, patient should not be very hungry.
Pradhana Karma:
Then for the administration of Basti, the patient will lie on the table in left lateral position with left leg straight and right leg flexed, his head should rest on his left flexed arm.
Then the anus and Basti Netra will be lubricated with oil.
Aushadh Dravyas (the therapeutic medication) filled in Basti Putaka will be administered through the anal route with the help of the Basti Netra which will be attached to Basti Putaka.
The Aushadh Dravya will be administered with constant pressure.
At last, the Basti Netra will be taken out of the anus slowly.
Paschata Karma:
Patient will be asked to lie down with his face upward after getting the urge he will eliminate the faeces sitting on his heels.
After defecation patient will be asked to take a bath with warm water and have a light meal.
Anuvasana Basti:
This will be done in the same way except in Poorva karma patient will be asked to have light meal prior to Basti Karma.
In Paschat Karma patient’s buttocks will be patted, lower abdomen will be massaged, legs will be raised for a while to increase the retention period.
)
(1) Medicine Name: LEKHNIYA BASTI : Makshik -60 ml ,Saindhava Lavan - 5 gms ,Til taila - 90 ml , Kalka Dravya - 2 gms each ,Kwath - 240 ml Kalka Dravyas: shilajatu, hingu, kasisa, tutha. Kwath Dravya: Triphala kwath. Gomutra – 50 ml Yavakshara – 2gm ; MURCHHITA TIL TAILA ANUVASANA BASTI: Kalka Dravya- Manjishtha, Triphla, Haridra, Musta, Vatt-jata, Nakula, Kevra-Phool. , Reference: Sushrut Sahimta, Chikitsa Sthan 38/82, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 455(ml), Frequency: od, Duration: 16 Days | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: LIPISTAB, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 40 Days, anupAna/sahapAna: Yes(details: -ushnoodaka), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients willing for study.
2. Patients between the age of 20 and 60 years.
3. If the values of Lipid Profile exceed than normal values. |
|
| ExclusionCriteria |
| Details |
1.Patients not willing for study.
2.Patients having serious cardiac problems as- Myocardial Infarction, malignant hypertension, cardiac failure.
3.Patients having major illness like- IDDM and chronic uncontrolled DM II.
4.Patients having any serious renal disorder, untreated Thyroid Disorder.
5.Drug induced Hyperlipidemia e.g. -Glucocorticoid induced.
6.Pregnant and lactating females
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It will lower the values of the lipid profile, including serum total cholesterol, triglycerides, low-density lipoproteins (LDL), high-density lipoproteins (HDL), very low-density lipoproteins (VLDL), and the ratio of HDL to total cholesterol. |
Assessment will be done in both the groups:
1.Day 20:At the end of the Basti. (for Group A)
2.Day 40:At the end of treatment. (For the Group B)
3.Day 60:At the time of follow up (For both the Groups A and B).
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Measurable improvement in the following subjective sign & symptoms:
1. Weight loss
2. Chala Sphik: Flabby or unfirm buttocks
3. Chala Udara: Flabby or unfirm abdomen
4. Chala Sthana: Flabby or unfirm chest or breasts
5. Anutsaha: Lack of enthusiasm or energy
6. Krichra Vyavaaya: Difficulty in sexual activity
7. Dourbalya: Weakness or fatigue
8. Dourgandhya: Foul body odor
9. Swedhabhaada: Excessive or abnormal sweating
10. Kshudhatimatra: Excessive hunger
11. Pipasatiyoga: Excessive thirst
|
Assessment will be done in both the groups:
1.Day 40:At the end of treatment(For the Group B).
2.Day 60:At the time of follow up (For both the Groups A & B). |
|
|
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)
|
05/02/2025 |
| 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
|
|
Brief Summary
|
The
total of 60 patients will be selected who are between age group of 20 to 60
years of either sex who are diagnosed with Medovaha Sroto Dushti on the
basis of sign/symptoms and Lab examination. Patients will be divided into two
groups (Trial Group A and Trial Group B).
Group
A will be given oral administration of Lipistab Tablet and Lekhniya Basti and
Group B will be given oral administration of Lipistab Tablet and conduct
a clinical study
to evaluate the effect of
oral administration of Lipistab Tablet in the management of Medovaha
Sroto Dushti w.s.r.
Hyperlipidemia;
to
evaluate the effect of oral administration Lipistab Tablet with Lekhniya
Basti in the management of Medovaha Sroto Dushti w.s.r.
Hyperlipidemia and
to compare the effect of
oral administration of Lipistab Tablet with and without Lekhniya Basti in
the management of Medovaha Sroto Dushti w.s.r. Hyperlipidemia.
The
total duration of study will be 18 months. |