| CTRI Number |
CTRI/2025/09/094349 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
04/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of Panchakarma in Grahani Roga |
|
Scientific Title of Study
|
Comparative Clinical Evaluation of Deepana-Pachana with Basti Karma and Kutaj Parpati in Vataj Grahani |
| 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 Ramola |
| Designation |
PG Scholar |
| Affiliation |
Uttarakhand Ayurved University, Gurukul campus, Haridwar |
| Address |
Department of Panchakarma, Gurukul Campus, Uttarakhand Ayurved University, Haridwar, Uttarakhand
Hardwar
UTTARANCHAL
249404
India |
| Phone |
8218243905 |
| Fax |
|
| Email |
ramolaroshni38@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mayank Bhatkoti |
| Designation |
Associate Professor |
| Affiliation |
Uttarakhand Ayurved University, Gurukul campus, Haridwar |
| Address |
Department of Panchakarma, Gurukul Campus, Uttarakhand Ayurved University, Haridwar, Uttarakhand
Hardwar
UTTARANCHAL
249404
India |
| Phone |
7351808758 |
| Fax |
|
| Email |
mayankbhatkotimd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Roshni Ramola |
| Designation |
PG Scholar |
| Affiliation |
Uttarakhand Ayurved University, Gurukul campus, Haridwar |
| Address |
Department of Panchakarma, Gurukul Campus, Uttarakhand Ayurved University, Haridwar, Uttarakhand
Hardwar
UTTARANCHAL
249404
India |
| Phone |
8218243905 |
| Fax |
|
| Email |
ramolaroshni38@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gurukul campus, Uttarakhand Ayurved University, Haridwar, Uttarakhand, Pin code - 249404 |
|
|
Primary Sponsor
|
| Name |
Gurukul campus Uttarakhand Ayurved University Haridwar |
| Address |
Uttarakhand Ayurved University, Gurukul campus, Haridwar, Uttarakhand, Pincode - 249404 |
| Type of Sponsor |
Government 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 Roshni Ramola |
Gurukul campus Uttarakhand Ayurved University Haridwar |
OPD No. 24
Department of Panchakarma Gurukul campus Uttarakhand Ayurved University Haridwar, Uttarakhand, Pincode - 249404
Hardwar
UTTARANCHAL |
8218243905
ramolaroshni38@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Uttarakhand Ayurved University, Dehradun |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K582||Mixed irritable bowel syndrome. Ayurveda Condition: VATAJAGRAHANIDOSHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | kAla-bastiH, काल-बस्तिः | (Procedure Reference: Charak Samhita, Procedure details: Sarvang Abhyanga-swedana done followed by Anuvasana Basti)
(1) Medicine Name: Bilwa Taila, Reference: Bhav Prakash Madhyam Khand, Route: Rectal, Dosage Form: Taila, Dose: 120(ml), Frequency: od, Duration: 10 Days | | 2 | Intervention Arm | Procedure | - | kAla-bastiH, काल-बस्तिः | (Procedure Reference: Charak Samhita, Procedure details: Sarvang Abhyang-swedana done followed by Asthapana Basti)
(1) Medicine Name: Shampakadi Asthapana, Reference: Sushruta Samhita, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 960(ml), Frequency: od, Duration: 06 Days | | 3 | Intervention Arm | Procedure | - | Deepana-Pachana | (Procedure Reference: Charak Samhita, Procedure details: Deepana-Pachana for 05 days before administration of Basti karma in Kala Basti Schedule)
(1) Medicine Name: Chitrakadi Vati, Reference: Charak Samhita Chikitsa Sthana Adhyaya 15, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 250(mg), Frequency: tds, Duration: 05 Days | | 4 | Comparator Arm | Drug | Classical | | (1) Medicine Name: KUTAJ PARPATI, Reference: CHIKITSA PRADIP, Route: Oral, Dosage Form: Parpati, Dose: 01(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: Takra), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients between 18-60 years of age group.
Patients having classical symptoms of Vataj Grahani as mentioned in Brihatatrayi and other Samhitas such as Annam Pachyate Dukham, Shuktapaka, Aadhmanam, Mana Sadnam, Aasyavairasya, Udarshoola, Dravashushka Tanu Apakwa Phenyukta Malapravrutti.
Patients who are fit for Basti Karma.
Diagnosed and treated cases of IBS. |
|
| ExclusionCriteria |
| Details |
Patients suffering from any systemic disorders like uncontrolled diabetes, hypertension, cardiac disease, thyroid disorders, renal dysfunction, which can interfere with the course of disease and treatment.
Life threatening disease like abdominal Koch’s, CA colon and partial abdominal obstruction will be excluded.
Patient with past history of surgery of GI tract. K/C/O – Amoebiasis, tropical sprue, ulcerative colitis, Crohn’s disease, celiac disease, gastric ulcers, intestinal obstruction. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment will be done on the basis of subjective parameters:
• Annam Pachyate Dukham (Difficulty in digestion)
• Shuktapaka(Dyspepsia)
• Aadhmanam (Abdominal distension)
• Mana Sadnam(Psychological disturbances)
• Aasyavairasya (Altered taste of mouth)
• Udarshoola (Abdominal pain)
• Drava Shushka Tanu Apakwa Phenyukta Malapravrutti
• Alteration of bowel habits
• Punah Punah Srijeta Varcha (Feeling of incomplete evacuation after defecation)
• Other symptoms. |
Assessment will be done at baseline, on 21th day and 15 days after completion of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess whether there are any additional significant findings |
At baseline, 21th day & 15 days after completion of treatment. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 |
|
Date of First Enrollment (India)
|
25/09/2025 |
| 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 Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [ramolaroshni38@gmail.com].
- For how long will this data be available start date provided 01-10-2026 and end date provided 02-01-1970?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This is a randomized, open-label, parallel-group clinical trial which aims to evaluate the efficacy of Deepana-Pachana along with Basti Karma and Kutaj Parpati in the management of Vataj Grahani, one of the commonest disorder of Annavaha Srotas as described in classical Ayurvedic texts, symptoms of which closely resembles to that of Irritable Bowel Syndrome (IBS). The study will be conducted at the Uttarakhand Ayurved University, Gurukul Campus Haridwar. A total of 30 patients diagnosed with Vataj Grahani will be selected from the OPD and IPD of the Department of Panchakarma and participants will be divided randomly into two groups of 15-15 patients in each group. Group A will receive Deepana-Pachana with Chitrakadi Vati and Kala Basti with Shampakadi Asthapana and Bilwa Taila Anuvasana, while Group B will be given Kutaj Parpati. The intervention is based on classical Ayurvedic references recommending Basti Chikitsa and Parpati Kalpana for Grahani Roga. Total duration of treatment will be of 21 days for both the groups and follow-up will be after 15 days of completion of treatment. The observation of the patients will be carried out before, during and after completion of treatment. The obtained results will be discussed on the basis of Ayurvedic concepts and modern scientific parameters. The whole research work will be summarized, and the results obtained on the basis of subjective parameters will be analysed statistically and conclusion will be derived. |