| CTRI Number |
CTRI/2024/11/077076 [Registered on: 20/11/2024] Trial Registered Prospectively |
| Last Modified On: |
19/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluate the efficacy of Shatapushpadi Basti in the management of Prameha (Diabetes mellitus) |
|
Scientific Title of Study
|
Randomized controlled clinical study to evaluate the efficacy of Shatapushpadi Basti in the management of Prameha (Diabetes mellitus) |
| 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 Ekta Suryabhan Tandekar |
| Designation |
PG Scholar |
| Affiliation |
C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011 |
| Address |
OPD No. 15 Panchakarma Department C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
7038258369 |
| Fax |
|
| Email |
ektatandekar14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Uday Keshvrao Neralkar |
| Designation |
Professor |
| Affiliation |
C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011 |
| Address |
OPD no. 15 Panchakarma Department C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad India 431011
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
9850035061 |
| Fax |
|
| Email |
uneralkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ekta Suryabhan Tanderkar |
| Designation |
PG Scholar |
| Affiliation |
C.S.M.S.S Ayurved Mahavidyala and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011 |
| Address |
OPD No 15 Panchakarma Department
C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanawdi Aurangabad Maharashtra India 431011
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
7038258369 |
| Fax |
|
| Email |
ektatandekar14@gmail.com |
|
|
Source of Monetary or Material Support
|
| C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011 |
|
|
Primary Sponsor
|
| Name |
C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011 |
| Address |
C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi, Paithan Road, Aurangabad Maharashtra India 431011 |
| 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 Ekta Suryabhan Tandekar |
C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431001 |
OPD No 15
Panchakarma
Department C.S.M.S.S.
Ayurved Mahavidyalaya
and Rugnalaya
Kanchanwadi
Aurangabad
Maharashtra
Aurangabad
MAHARASHTRA
Aurangabad
MAHARASHTRA |
7038258369
ektatandekar14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CSMSS Ayurved Mahavidyalaya and Rugnalaya, Aurangabad |
Not Applicable |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E00-E89||Endocrine, nutritional and metabolic diseases. Ayurveda Condition: PRAMEHA-ARISHTAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Basti karma | (Procedure Reference: charak siddhisthan, Procedure details: After snehan swedan ask patient to lie down in left lateral postion .
luke warm basti will be taken in basti yantra.665 ml shatpushapadi basti wiil be taken .
Tila taila will be taken for anuvasan basti .
Lubrication of anus will be done by tila taila.
Basti will be administered slowly with equal pressure, without any jerk.)
(1) Medicine Name: Shatapupshadi Basti, Reference: charak siddisthan 12/13, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 665(ml), Frequency: od, Duration: 8 Days | | 2 | Comparator Arm | Procedure | - | Basti karma | (Procedure Reference: Charak siddhisthan, Procedure details: After snehan swedana ask patient to lie down in left lateral position.
Luke warm basti will be taken in basti yantra. 480 ml of madhutailika basti will be taken.
Lubrication of anus will be done by tila taila.
Basti will be administered slowly with equal pressure, without any jerk)
(1) Medicine Name: Madhutailika basti , Reference: Ashtang Hrudaya kalpasathan 4/27/28, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 480(ml), Frequency: od, Duration: 8 Days |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Clinically diagnosed patient of prameha .
Patient with Diabetes mellitus type II.
Subject having their fasting blood sugar more than 126 mg/dl and postmeal sugar more than 200mg/dl,
B.M.I range 18 to 25 kg/m2
Basti chikitsa yogya patients.
Patient willing for trial and giving written consent. |
|
| ExclusionCriteria |
| Details |
Patient below age 30 and above 60 years.
patient with diabetes type I.
DM associated with following condition - Pregnancy ,Lactating women ,moderate to sever cardiovascular disease aand kidney disorder ,k/c/o any malignancy,k/c/o TB
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Polyuria will be decreased
Polydipsia will be decreased
Polyphagia will be decreased.
|
24 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Perspiration will be decreased.
Burning sensation will be decreased.
Tingling sensation will be decreased. |
24 days |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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)
|
01/12/2024 |
| 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
|
Nidanas (etiological factors) of Prameha according to Ayurved are said to be ’Asyasukham’ (sedentary lifestyle), ’Swapnasukham’ (excessive sleep), intake of ’Kaphakar ahara’ (food that causes vitiation of kapha dosha ), which collectively leads to Prameha. Predominant factors contributing to Prameha samprapti are kapha dushti (vitiated kapha dosha) which leads to agnimandya (decrease digestive fire) which further leads to Kleda utpatti and this kleda causes Strotorodha (obstructive pathology). To break this etiopathology, Ayurved has explained panchakarma,out of them one is basti . Achraya charak explained pramehaghana basti in siddhisthan ,12th adhyay. Selection of basti chikitsa in Prameha which contains contents of opposite Gunas (properties) of Prameha pathology may help break its pathology. So here Shatapushpadi Basti is selected.
Study will be conducted 92 diagonsed patient of Diabetes mellitus type II. Written consent will be taken. Initial assesment will be done. Patient treated with interventional group shatpushpadi basti and control group Madhutailika basti . Patient assessed at follow up. Observation and result will be note and statistical analysis. Discussion and conclusion will be done.
Null Hypothesis: Shatapushpadi Basti is not effective in Prameha (Diabetes Mellitus). Alternative Hypothesis: Shatapushpadi Basti is effective in the management of Prameha (Diabetes Mellitus). |