| CTRI Number |
CTRI/2024/09/073637 [Registered on: 09/09/2024] Trial Registered Prospectively |
| Last Modified On: |
05/09/2024 |
| 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 study the effect of previrechana diet |
|
Scientific Title of Study
|
Efficacy of modified previrechana diet to obtain samyak virikta laksana in diabetic erectile dysfunction A Randomized controlled trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Roshni P |
| Designation |
PG Scholar |
| Affiliation |
Vaidyaratnam P S Varrier Ayurveda College |
| Address |
Department of panchakarma
Vaidyaratnam P S Varier Ayurveda College Kottakkal
Edarikode PO Malappuram
Kerala
Malappuram
KERALA
676501
India |
| Phone |
9037122972 |
| Fax |
|
| Email |
drroshniayur@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jigeesh P P |
| Designation |
Professor |
| Affiliation |
Vaidyaratnam P S Varrier A yurveda College |
| Address |
Department of panchakarma
Vaidyaratnam P S Varier Ayurveda College Kottakkal
Edarikode PO Malappuram
Kerala
Malappuram
KERALA
676501
India |
| Phone |
9447997436 |
| Fax |
|
| Email |
drjigeesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jigeesh P P |
| Designation |
Professor |
| Affiliation |
Vaidyaratnam P S Varrier A yurveda College |
| Address |
Department of Panchakarma Vaidyaratnam P S Varier Ayurveda College Kottakkal
Edarikode PO Malappuram
Kerala
Malappuram
KERALA
676501
India |
| Phone |
9447997436 |
| Fax |
|
| Email |
drjigeesh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vaidyaratnam P S Varrier Ayurveda College kottakkal
Edarikode(p.o), Malappuram(dist), kerala 676501 |
|
|
Primary Sponsor
|
| Name |
Vaidyaratnam PS Varrier Ayurveda College Kottakkal |
| Address |
Department of Panchakarma Vaidyaratnam PS Varrier Ayurveda College Kottakkal Malappuram Kerala 676501 |
| Type of Sponsor |
Other [aided 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 Roshni P |
Vaidyaratnam PS Varrier Ayurveda College |
OPD Department of Panchakarma Room number A112 Vaidyaratnam PS Varrier Ayurveda College Kottakkal Edarikode PO malappuram Kerala 676501
Malappuram
KERALA |
9037122972
drroshniayur@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Vaidyaratnam P S Varrier Ayurveda College kottakkal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N521||Erectile dysfunction due to diseases classified elsewhere. Ayurveda Condition: KLAIBYAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | virecana-karma, विरेचन-करà¥à¤® | (Procedure Reference: Vagbhata. Astangasamgraha(Indu,comme), sutrasthana, Ch27/26 srikanthamurthy KR, editor. Varanasi: Chaukambha Orientalia; 2005. 207pSanskrit 4. Susruta. SusrutaSamhita(Dalhana,comme), chikitsasthana, Ch33/20, Jadavji trikamji, editor. Varanasi :Chaukambha surbharati prakashan; 2019. 518pSanskrit, Procedure details: deepana pachana hinguvachadi choornam
snehapana sanmali ghrtm
utklesa diet lemonrice followed with hot lemon water
virechana with vidangatanduladi choornam)
(1) Medicine Name: vidangatanduladi choornam, Reference: Vagbhata. Astangahrdaya(Arunadatta,Hemadri), kalpasthanaCh2/15,16, Hari sadasiva sastri paradakara, editor. Varanasi:Chaukambha Orientalia; 2005. 843pSanskrit, Route: Oral, Dosage Form: Churna/ Powder, Dose: 30(g), Frequency: od, Duration: 1 Days | | 2 | Comparator Arm | Procedure | - | virecana-karma, विरेचन-करà¥à¤® | (Procedure Reference: Vagbhata. Astangasamgraha(Indu,comme), sutrasthana, Ch27/26 srikanthamurthy KR, editor. Varanasi: Chaukambha Orientalia; 2005. 207pSanskrit 4. Susruta. SusrutaSamhita(Dalhana,comme), chikitsasthana, Ch33/20, Jadavji trikamji, editor. Varanasi :Chaukambha surbharati prakashan; 2019. 518pSanskrit, Procedure details: deepana pachana with hinguvachadi choornam
snehapana with sanmali ghrtm
virecana with vidangatanduladi choornam)
(1) Medicine Name: vidangatanduladi choornam, Reference: Vagbhata. Astangahrdaya(Arunadatta,Hemadri), kalpasthanaCh2/15,16, Hari sadasiva sastri paradakara, editor. Varanasi:Chaukambha Orientalia; 2005. 843pSanskrit, Route: Oral, Dosage Form: Churna/ Powder, Dose: 30(g), Frequency: od, Duration: 1 Days |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Male |
| Details |
Participants fulfilling the diagnostic criteria
HbA1c less than 9.5% with medication
Mild Moderate and Mild to moderate ED more than 6 months
Those who are fit for virechana
Participants willing to give informed consent
|
|
| ExclusionCriteria |
| Details |
Known case of Genital anatomical deformities
Known case of Malignancies
Known case of Chronic kidney disease
Known case of Type 1 diabetes
Known case of insulin dependent diabetes
Known case of Diabetic nephropathy
Known case of Major psychiatric disorders
Known case of gastro oesophageal reflex disease
Alcoholism or substance abuse
Spinal cord injury
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| samyak virikta laksana assesment |
on the day of virechana |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the efficacy of modified previrechana diet in producing Pittotkleśa symptoms among Diabetic erectile dysfunction
To assess the efficacy of virechana in diabetic erectile dysfunction.
|
Pittotkleśa lakṣaṇa chart on 1st,2nd,3rd day of visrama kala & on the day of virechana
IIEF-5 on 0th day & after 4 weeks
|
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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
|
N/A |
|
Date of First Enrollment (India)
|
16/09/2024 |
| 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
|
For obtaining optimum virechana, pūrvakarmas are essential. Along with this specific dietary regimens are also advised in order to facilitate the purification. Therefore a modified diet in the form of lemon rice and lime water is administered for pittotkleśa. Erectile dysfunction (ED) is a common and distressing complication of diabetes. The underlying etiology of Diabetic ED is organic rather than psychogenic. Klaibya can be assumed as complication of Prameha comes under the spectrum of santarpanotha vyadhi and is indicated for shodhana. Sanmali ghŕta is a unique formulation indicated for prameha and klaibya. The current work, a RCT is planned to compare significance of modified diet in producing Samyak viriktha lakṣaṇa in diabetic erectile dysfunction. 36 participants satisfying diagnostic and inclusion criteria will be taken and randomized to two groups. Trial group will be administerd with modified diet and control group will be administered with normal diet. Assessments will be done using Samyak viriktha lakṣaṇa chart and pittotkleśa lakṣaṇa chart. Data collected will be analysed using Mann Whitney U test and independent T test. The outcome will be submitted in the form of dissertation |