| CTRI Number |
CTRI/2026/01/100362 [Registered on: 05/01/2026] Trial Registered Prospectively |
| Last Modified On: |
03/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Gandhaka druti pichu and yastimadhu tailas pichu in the management of parikartika with special reference to acute fissure -in -ano |
|
Scientific Title of Study
|
A Comparative clinical study to evaluate the efficacy of gandhaka druti pichu and yastimadhu tailas pichu in the management of parikartika with special reference to acute 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 Rajkumar Gupta |
| Designation |
Shalya tantra post graduate scholar |
| Affiliation |
Jeevan Jyoti Ayurvedic Medical College and Hospital Aligarh |
| Address |
Department of pg studies in shalya tamtra , Jeevan Jyoti Ayurvedic Medical College and Hospital,10th K.M Mile Stone , Khair Road ,Lodha,Aligarh Jeevan Jyoti Ayurvedic Medical College and Hospital,10th K.M Mile Stone , Khair Road ,Lodha,Aligarh Aligarh UTTAR PRADESH 202140 India |
| Phone |
08090040289 |
| Fax |
|
| Email |
rrrgupta28@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR YATI TIWARI |
| Designation |
Professor in department of shalya tantra |
| Affiliation |
Jeevan Jyoti Ayurvedic Medical College and Hospital Aligarh |
| Address |
Department of pg studies in shalya tamtra , Jeevan Jyoti Ayurvedic Medical College and Hospital,10th K.M Mile Stone , Khair Road ,Lodha,Aligarh Jeevan Jyoti Ayurvedic Medical College and Hospital,10th K.M Mile Stone , Khair Road ,Lodha,Aligarh Aligarh UTTAR PRADESH 202140 India |
| Phone |
8445733813 |
| Fax |
|
| Email |
Yati_tiwari@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
DR YATI TIWARI |
| Designation |
Professor in department of shalya tantra |
| Affiliation |
Jeevan Jyoti Ayurvedic Medical College and Hospital |
| Address |
Department of pg studies in shalya tamtra , Jeevan Jyoti Ayurvedic Medical College and Hospital,10th K.M Mile Stone , Khair Road ,Lodha,Aligarh Jeevan Jyoti Ayurvedic Medical College and Hospital,10th K.M Mile Stone , Khair Road ,Lodha,Aligarh Aligarh UTTAR PRADESH 202140 India |
| Phone |
8445733813 |
| Fax |
|
| Email |
Yati_tiwari@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of PG Studies in Shalya Tantra,Jeevan Jyoti Ayurvedic Medical College and Hospital, 10th K.m Mile Stone,Khair Road ,Lodha,Aligarh-202140 |
|
|
Primary Sponsor
|
| Name |
Jeevan Jyoti Ayurvedic Medical College and Hospital |
| Address |
Jeevan Jyoti Ayurvedic Medical College and Hospital,10th K.M Mile Stone , Khair Road ,Lodha,Aligarh |
| 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 Rajkumar Gupta |
Jeevan Jyoti Ayurvedic Medical College and Hospital |
Department of pg studies in shalya tamtra , Jeevan Jyoti Ayurvedic Medical College and Hospital,10th K.M Mile Stone , Khair Road ,Lodha,Aligarh Aligarh UTTAR PRADESH |
08090040289
rrrgupta28@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee |
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 | Comparator Arm | Procedure | - | picu, पिचु | (Procedure Reference: Acharya sushruta in sushruta samhita chikitsa sthana 1st chapter explained about pichu in the management of vrana, Procedure details: Patient will be educated about the procedure. patient will be advised to clean the peri anal region then after taking the comfortable position advised to insert the medicated pichu in the anal region. patient will be advised to remove it after 6 hours) (1) Medicine Name: Gandhaka dhruti, Reference: Pandit kashinath sastri in rasaratnataringini 8th taranga explained about the gandhaka in the management of gudagata vikriti, Route: Rectal, Dosage Form: Taila, Dose: 5(ml), Frequency: bd, Duration: 7 Days | | 2 | Intervention Arm | Procedure | - | picu, पिचु | (Procedure Reference: Acharya sushruta in sushruta samhita chikitsa sthana 1st chapter explained about pichu in the management of vrana., Procedure details: Patient will be educated about the procedure. patient will be advised to clean the peri anal region then after taking the comfortable position advised to insert the medicated pichu in the anal region. patient will be advised to remove it after 6 hours) (1) Medicine Name: Yastimadhu taila, Reference: Acharya sushruta in sushruta samhita chikitsa sthana 34th chapter explained about yastimadhu taila in parikartika, Route: Rectal, Dosage Form: Taila, Dose: 5(ml), Frequency: bd, Duration: 7 Days |
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient diagnosed with parikartika.
Patients with diabetes and hypertension which are under control.
|
|
| ExclusionCriteria |
| Details |
Patients diagnosed with the other co -existing ano rectal disease.
Fissure in ano due to systemic disorder.
Patient suffering from infectious disease.
Patients of chronic fissure in ano with sentinel pile.
Pregnant and lactating women
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in pain |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in quality of life Reduction in associated symptoms such as constipation. |
15 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
|
N/A |
|
Date of First Enrollment (India)
|
14/01/2026 |
| 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="0" Months="0" Days="15" |
|
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
|
Parikartika is one of the most painful and commonest condition in Gudagata Vikaras affecting majority of the population in modern world. Acharya’s have explained it as one among the Vamana Virechana Vyapat and Bastivyapat. It is caused by Sthana Samshraya of vitiated Vata & Pitta Dosha’s in Gudapradesh, leading to Kartanavat Vedana and Daha in Gudapradesh.It can be correlated to fissure-in-ano based on signs and symptoms.Fissure-in-ano is an elongated ulcer in longitudinal axis of lower anal canalassociated with constipation, severe pain & burning sensation during defecation and bright red bleeding. In acute type pain is so severe that, patient develops fear for defecation and this further worsens the condition. Fissure-in-ano occurs most commonly in midline posteriorly, in males usually posteriorly 95%, anteriorly 5%, & in females posteriorly 80%, & anteriorly 20%.About 30–40% of the population suffers from proctologic pathologies at least once in their lives, that anal fissure comprises of 10–15%. It occurs equally in both men & women andis common in all age groups especially adults of 15-40 years.The incident is upposed to be high in one who passes hard & dry stool.In the Chikitsa of Parikartika, Acharyas have mentioned Madhura, Kashaya Rasa Sneha Yukta Dravya’s in the form of Piccha Basti, Anuvasana Basti, Pichu, Varti & Lepa, which pacifies Vata and Pitta Dosha’s.Acharya Sushrutha has mentioned Pichu Prayoga in the context of Shashti Upakrama, in the management of Vrana. Yastimadhu Taila is having Vata-Pittahara Guna, Sheeta Veerya, which acts as Dahaprashamaka and Vranaropaka, hence it is taken as standard drug by previous research worksdone.Gandhaka Druti is mentioned in Rasa Ratna Samucchaya in the context of Uparasas,It is Taila obtained of Gandhaka, which acts as Vedanasthapaka and Vranaropaka, so it has been selected in the treatment of Parikartika.These drugs are easily available and suitable for local application in Parikartika w.s.r. acute fissure in ano. Hence the present study is under taken to evaluate and compare the efficacy of Gandhaka DrutiPichu and Yastimadhu Taila Pichu in the management of Parikartika w.s.r to Acute Fissure-in-Ano. |