| CTRI Number |
CTRI/2025/03/082227 [Registered on: 12/03/2025] Trial Registered Prospectively |
| Last Modified On: |
11/03/2025 |
| 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 study the efficacy of bhu dhatriyadi taila pichu in the management of parikartika. |
|
Scientific Title of Study
|
Randomised control clinical trial to evaluate the efficacy of bhu dhatriyadi taila pichu in the management of parikartika with special reference to fissure in ano. |
| 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 Dixita Devendra Kusvaha |
| Designation |
PG Scholar |
| Affiliation |
Late Kedari Redekar Ayurvedic Mahavidyalaya |
| Address |
Late Kedari Redekar Ayurvedic Mahavidyalaya Shalya Department opd no 4 male and female wardGadhinglaj Kolhapur
Pin 416502
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
7710841424 |
| Fax |
|
| Email |
kushvahadixita@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amitkumar Bhimsing Pundpal |
| Designation |
Professor |
| Affiliation |
Late Kedari Redekar Ayurvedic Mahavidyalaya |
| Address |
Late Kedari Redekar Ayurvedic Mahavidyalaya Shalya Department shalya opd no 4 male and female ward Gadhinglaj Kolhapur
416502
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9420779594 |
| Fax |
|
| Email |
dramitpundpal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amitkumar Bhimsing Pundpal |
| Designation |
Professor |
| Affiliation |
Late Kedari Redekar Ayurvedic Mahavidyalaya |
| Address |
Late Kedari Redekar Ayurvedic Mahavidyalaya Shalya Department shalya opd no 4 male and female ward Gadhinglaj Kolhapur
416502
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9420779594 |
| Fax |
|
| Email |
dramitpundpal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Daily opd and ipd patients of late kedari redekar dharmaday hospital gadhinglaj 416502 |
|
|
Primary Sponsor
|
| Name |
Dr. Dixita Devendra Kusvaha |
| Address |
Late Kedari Redekar Ayurvedic Mahavidyalaya Gadhinglaj Kolhapur India
Pin code -416502 |
| Type of Sponsor |
Other [Self] |
|
|
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 Dixita Devendra Kusvaha |
Late Kedari Redekar Dharmaday Rugnalaya, Gadhinglaj |
Late Kedari Redekar Ayurvedic mahavidyalaya shalya department Room no.3 shalya OPD, Gadhinglaj, kolhapur
Pin-416502
Kolhapur
MAHARASHTRA |
7710841424
kusvahadixita@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Late Kedari Redekar Ayurvedic Mahavidyalaya Gadhinglaj Kolhapur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K600||Acute anal fissure. Ayurveda Condition: PARIKARTIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | picu, पिचु | (Procedure Reference: Bhaishyaja ratnakar, Procedure details: Application of taila with the help of pichu dharan morning and evening after defecation)
(1) Medicine Name: Bhudhatryadi taila, Reference: Bhaishyaja ratnakar, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: bd, Duration: 21 Days | | 2 | Comparator Arm | Procedure | - | picu, पिचु | (Procedure Reference: Sharangdhar samhita, Procedure details: Application of jatyadi taila locally with the help of pichu in morning and evening after defecation)
(1) Medicine Name: Jatyadi taila, Reference: Sharangdhar samhita madhyam khanda, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: bd, Duration: 21 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
The cases will be randomly selected irrespective of sex Chronicity dosha
and type of fissure Acute fissure in ano.
|
|
| ExclusionCriteria |
| Details |
Patient below 18 years and above 60 years of age.
- Known / suspected case of malignancy of anus or rectum.
- Multiple fissures in ano as a complication of skin disease.
- Known case of STD, HIV infection and other infectious disease.
- Fissure secondary to Fistula in ano, Ulcerative colitis, Tuberculosis,
Syphilis, Chron’s disease other Systemic Disease pertaining to Colo-
Rectum etc.
- Uncontrolled Diabetes Mellitus, Tuberculosis of rectum.
- Pregnancy.
- Fissure more than 2. |
|
|
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 |
| Bhudhatryadi tail pichu is effective in the management of acute fissure in ano |
Within 21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Bhudhatryadi tail pichu is more effective than jatyadi taila pichu in the management of acute fissure in ano |
Within 21 days |
|
|
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)
|
10/04/2025 |
| 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
|
|
Brief Summary
|
In today’s era, there are large number of people affected with anorectal
diseases like fissure in ano. At present the prevalence rate of this disease
is 11%. Also, it is estimated to be increased over large scale in the coming
era due to the changing lifestyle.
• The treatment of acute fissure is most likely of conservative nature with
oral painkillers, stool softener’s, soothing ointments or injection of long-
acting anaesthetizing drug, surgical procedures like Lords dilatation,
Sphincterotomy¹Fissurectomy and excision of anal ulcer gives relief but
• Ayurveda being an ancient science has mentioned Pichha basti Anuvasan
basti, Parishek Pichu and local administration of sneha dravyas which
relieve Vaat and Pitta in the management of Parikartika. Pichu being the
most easy ,effective and less time consuming therefore Bhu-dhatriyadi3
taila mentioned in Vaidya Manorama(Bharat Bhaishajya Ratnakar), having
properties of vedanasthapan, vrana shodhan, vrana ropan is been chosen
formats study.
|