| CTRI Number |
CTRI/2025/11/097478 [Registered on: 17/11/2025] Trial Registered Prospectively |
| Last Modified On: |
14/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A Study on the Role of Artavavaha Srotas (Reproductive Channels) in Women with Polycystic Ovary Syndrome (PCOS) |
|
Scientific Title of Study
|
An Anatomico clinical study of Artavavaha srotas WSR to PCOS |
| 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 GUPTA MOHINI SHEETALA PRASAD |
| Designation |
MD SCHOLAR |
| Affiliation |
State Ayurvedic College and Hospital |
| Address |
State Ayurvedic College and Hospital, PG Department of Rachana Sharir, Tulsidas marg, Turiyaganj, Lucknow 226004, UP
Lucknow
UTTAR PRADESH
226004
India |
| Phone |
9565211515 |
| Fax |
|
| Email |
mohinigpta1995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ARVIND KUMAR |
| Designation |
MD, PhD, LECTURER |
| Affiliation |
State Ayurvedic College and Hospital |
| Address |
State Ayurvedic College and Hospital, PG Department of Rachana Sharir, Tulsidas marg, Turiyaganj, Lucknow 226004, UP
Lucknow
UTTAR PRADESH
226017
India |
| Phone |
9935039819 |
| Fax |
|
| Email |
drarvind1973@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ARVIND KUMAR |
| Designation |
MD, PhD, LECTURER |
| Affiliation |
State Ayurvedic College and Hospital |
| Address |
State Ayurvedic College and Hospital, PG Department of Rachana Sharir, Tulsidas marg, Turiyaganj, Lucknow 226004, UP
Lucknow
UTTAR PRADESH
226017
India |
| Phone |
9935039819 |
| Fax |
|
| Email |
drarvind1973@gmail.com |
|
|
Source of Monetary or Material Support
|
| State Ayurvedic College and Hospital, Tulsidas Marg, Turiyaganj, lucknow 226004, UP, India. |
|
|
Primary Sponsor
|
| Name |
State Ayurvedic College and Hospital |
| Address |
State Ayurvedic College and Hospital, Tulsidas marg, Turiyaganj, Lucknow 226004, UP |
| 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 GUPTA MOHINI SHEETALA PRASAD |
STATE AYURVEDIC COLLEGE AND HOSPITAL |
State Ayurvedic College and Hospital, PG Department of Rachana Sharir, Tulsidas marg, Turiyaganj, Lucknow 226004, UP
Lucknow
UTTAR PRADESH |
9565211515
mohinigpta1995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| State Ayurvedic College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E282||Polycystic ovarian syndrome. Ayurveda Condition: ARTAVAVAHA-SROTODUSHTIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: yes, Ritucarya: yes, Acara Rasayana:yes, Other:, Pathya/Apathya:yes, Pathya:, Apathya: | | 2 | Comparator Arm | Lifestyle | - | - | Dinacarya: yes, Ritucarya: yes, Acara Rasayana:yes, Other:, Pathya/Apathya:yes, Pathya:, Apathya: |
|
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.60 cases will be taken between the age group of 18 years and 40 years.
2.Cases will be followed from the OPD with symptoms of artavavaha strotodushti associated with PCOS, amenorrhea or irregular menstruation, dyspareunia, hirsutism, obesity, infertility.
3.Patients showing polycystic ovaries in the USG will be taken. |
|
| ExclusionCriteria |
| Details |
1.Cases will not be taken under 18 years and above 40 years age group.
2.Cases will not be taken of those suffering from any other systemic diseases or local pathology of genital tract.
3.Patients suffering from any genetic disorder. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.The Artavavaha srotas and their moola i.e Garbhashaya and Artavavaha dhamani need to be explored under the light of modern science.
2.Role of srotodushti i.e Atipravratti, Sanga, Vimarga gamana and Sirajgranthi in the pathogenesis of PCOS need to be explored.
3.To establish a correlation between PCOS and Artavavaha srotodushti with respect to its anatomical and physiological changes. |
24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
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)
|
25/11/2025 |
| 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="0"
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 the context of Artavavaha Srotodushti, Polycystic Ovarian Syndrome (PCOS) is emerging as a steadily increasing concern among both adolescents and adults, manifesting through symptoms such as amenorrhea, obesity, hirsutism, and infertility. In the present era, it is essential to bring focused attention to this disorder. The causes and clinical features of PCOS show significant similarities with Artavavaha Srotodushti as described in Ayurveda. Given the absence of a definitive curative treatment in modern medicine, exploring PCOS through the Ayurvedic lens—particularly with reference to Artavavaha Srotodushti—may offer new insights and therapeutic possibilities. Therefore, I have chosen this topic to establish a correlation between PCOS and Artavavaha Srotodushti, focusing on anatomical and physiological aspects, lifestyle and dietary influences, and the predominance of doshas in women aged 18 to 40 years diagnosed with PCOS. The study will be conducted on 60 patients. |