| CTRI Number |
CTRI/2025/09/095233 [Registered on: 22/09/2025] Trial Registered Prospectively |
| Last Modified On: |
19/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Niruha basti with Kaphaghana dravyas will be given in Kaphaja Granthi(PCOS) in 50 participants.
|
|
Scientific Title of Study
|
Role of Niruha Basti in Kaphaja granthi(Polycystic Ovarian Syndrome) |
| 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 Monika |
| Designation |
PG Scholar Panchakarma |
| Affiliation |
Patanjali Ayurveda Hospital Patanjali Yogpeeth Phase 1 Haridwar Uttarakhand UTTARANCHAL249405 India |
| Address |
Panchakarma Department Opd No. 4 Patanjali Ayurveda Hospital
Patanjali Yogpeeth Phase 1 Roorkee Road Haridwar Uttarakhand UTTARANCHAL249405 India
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9780548290 |
| Fax |
|
| Email |
mokadalal46@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ketan Mahajan |
| Designation |
Professor(H.O.D) |
| Affiliation |
Patanjali Ayurveda Hospital Patanjali Yogpeeth Phase 1 Haridwar Uttarakhand UTTARANCHAL249405 India |
| Address |
Panchakarma Department OPD No. 4,Patanjali Ayurveda Hospital
Patanjali Yogpeeth Phase 1 Haridwar Uttarakhand,249405 India
Hardwar
UTTARANCHAL
249405
India |
| Phone |
8979793731 |
| Fax |
|
| Email |
ketanmahajan82@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Monika |
| Designation |
PG Scholar Panchakarma |
| Affiliation |
Patanjali Ayurveda Hospital Patanjali Yogpeeth Phase 1 Haridwar Uttarakhand UTTARANCHAL249405 India |
| Address |
Panchakarma Department Opd No. 4 Patanjali Ayurveda Hospital
Patanjali Yogpeeth Phase 1 Roorkee Road Haridwar Uttarakhand UTTARANCHAL249405 India
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9780548290 |
| Fax |
|
| Email |
mokadalal46@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar Patanjali Yogpeeth Phase 1 Haridwar Uttarakhand Pin code-249405 India |
|
|
Primary Sponsor
|
| Name |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar |
| Address |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar Patanjali Yogpeeth Phase 1 Haridwar Uttarakhand Pin code-249405 India |
| 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 Monika |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan,Haridwar,Uttarakhand |
Panchakarma Department, OPD No. 4,23
Hardwar
UTTARANCHAL |
09780548290
mokadalal46@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Patanjali Ayurveda College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E282||Polycystic ovarian syndrome. Ayurveda Condition: KAPAJAGRANTHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Charak Samhita Siddhisthan 10/23, Procedure details: Procedure reference:Charak Samhita Sidhhisthan 10/23.Basti will be administered alternately in Yoga basti schedule,Reference-Ashtanga Hridayam Sutrasthan 19/64.Anuvasana Basti:POORVA KARMA-Patient will be given Abhyanga and Swedan followed with warm water bath and then patient will be advised to take food less by ¼ of the usual quantity him to eliminate feaces, urine or flatus if present.PASCHAT KARMA-Patient will be asked to lie down comfortably on his left side to keep his head on his arms in the form of pillow while keeping the body straight and relaxed. Then the patient will be asked to flex his right leg over his fully extended left leg. Thereafter anus and enema nozzle will be lubricated with oil. After removing air bubble, appropriate quantity of prepared Anuvasana Basti will be administered with Triphala oil.PASCHAT KARMA-Buttocks of the patient will be patted with palms for 3 times and will be advised to relax in supine position. Patient will be advised to empty his bowel after getting urge for defecation. Niruha Basti:POORVA KARMA-After passing feaces, urine and flatus, the patient on empty stomach should be prepared with Abhyanga and Swedan. However, patient should not be hungry.PRADHAN KARMA-Patient will be asked to lie down comfortably on his left side to keep his head on his arms in the form of pillow while keeping the body straight and relaxed. Then the patient will be asked to flex his right leg over his fully extended left leg. Thereafter anus and enema nozzle will be lubricated with oil. After removing air bubble, appropriate quantity of prepared Niruha Basti will be administered.PASCHAT KARMA-Patient will be advised to lie on his back i.e in supine position comfortably on the bed. Patient will be advised to empty his bowel after getting urge for defecation. Duration: Basti will be administered(8 days)for 3 consecutive months.)
|
|
|
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Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1)Both Unmarried and Married Female patients of Age group - 14 to 45 years
2)Diagnosed patient of PCOS by USG presented with symptoms- Amenorrhoea, Oligomenorrhoea, Acne, Hirsutism, Acanthosis nigricans.
3)Patient fit for Basti.
|
|
| ExclusionCriteria |
| Details |
1)Patients suffering from Thyroid Abnormalities.
2)Hyperprolactinemia.
3)Patients suffering from uncontrolled HTN, Diabetes Mellitus, Cardiac diseases.
4)Patient unfit for Basti.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Parameters that will be assessed:
1)Oligomenorrhoea
2)Amenorrhoea |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Ultrasonography {Abdomen & Pelvis}
2)S. LH
3)S. FSH
4)S. Prolactin
|
90 days |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
30/09/2025 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This study is Role of Niruha Basti in Kaphaja Granthi(Polycystic Ovarian Syndrome). This will be conducted on 50 selected patients from Opd/Ipd of Panchakarman department of Patanjali Bhartiya Ayurvigyan Evum Anusandhan Sansthan Haridwar. Basti will be Administered with Kaphaghana Dravyas in Yoga Basti schedule for 8 days. Follow up will be taken after 1 month and Basti will be given for 2 more consecutive months. Assessment to be done on the Basis of Subjective and Objective parameters as discussed earlier. |