| CTRI Number |
CTRI/2025/05/086749 [Registered on: 13/05/2025] Trial Registered Prospectively |
| Last Modified On: |
11/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study to Evaluate the Effect of Brihatyadi Kashaya and Sahacharadi Kashaya Enema Therapy in the Management of Female Infertility |
|
Scientific Title of Study
|
A Randomised Open-Labeled Comparative Clinical Study to Evaluate the Efficacy of Brihatyadi Yapana Basti and Sahacharadi Yapana Basti in the Management of Stree Vandhyatwa with Special Reference to Aberrant Folliculogenesis |
| 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 Chetana Patil |
| Designation |
PG scholar |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research Hospital, Bengaluru |
| Address |
Department of P.G. Studies in Prasuti Tantra and Stree Roga
Sri Sri College of Ayurvedic Science and Research Hospital, Kanakapura Road, Udayapura P.O.,
Bengaluru – 560082, Karnataka, India
Bangalore
KARNATAKA
560082
India |
| Phone |
9845213622 |
| Fax |
|
| Email |
drchetana.gyn@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rachana H V |
| Designation |
Professor |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research Hospital, Bengaluru |
| Address |
Department of P.G. Studies in Prasuti Tantra and Stree Roga
Sri Sri College of Ayurvedic Science and Research Hospital, Kanakapura Road, Udayapura P.O.,
Bengaluru – 560082, Karnataka, India
Bangalore
KARNATAKA
560082
India |
| Phone |
9535744077 |
| Fax |
|
| Email |
dr.rachanabhat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chetana Patil |
| Designation |
PG scholar |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research Hospital, Bengaluru |
| Address |
Department of P.G. Studies in Prasuti Tantra and Stree Roga
Sri Sri College of Ayurvedic Science and Research Hospital, Kanakapura Road, Udayapura P.O.,
Bengaluru – 560082, Karnataka, India
Bangalore
KARNATAKA
560082
India |
| Phone |
9845213622 |
| Fax |
|
| Email |
drchetana.gyn@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Sri College of Ayurvedic Science and Research Hospital, Kanakapura Road, Udayapura P.O.,
Bengaluru – 560082, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Dr Chetana Patil |
| Address |
Sri Sri College of Ayurvedic Science and Research Hospital, Kanakapura Road, Udayapura P.O.,
Bengaluru – 560082, Karnataka, India |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH |
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH HOSPITAL 21ST KM OB CHUDAHALLI, KANAKPURA ROAD, BENGALURU- 560082 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Chetana Patil |
Sri Sri College of Ayurvedic Science and Research Hospital |
Department of P.G. Studies in Prasuti Tantra and Stree Roga Room No. 10, Kanakapura Road, Udayapura P.O.,
Bengaluru – 560082, Karnataka, India
Bangalore
KARNATAKA |
9845213622
drchetana.gyn@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Sri Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:Z318||Encounter for other procreative management. Ayurveda Condition: VANDHYA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | yApana-bastiH, यापन-बस्तिः | (Procedure Reference: Prof Chandrabhushan Jha, editor. Sharangadhara Samhita, Uttatara Khand, Niruha Basti Adhyaya: Chapter 6, Verse 3. Varanasi: Chaukhambha Surbharti Prakashan, 2006; p.330., Procedure details: Group-1 (15 Patients)- Kala Basti for 9 days
Day 1 - morning- Sahacharadi taila Anuvasana Basti after food
Day 2 to Day 7- Morning- Brihatyadi yapana basti in empty stomach, Afternoon- Sahacharadi Anuvasana after food.
Day 8 to Day 9 - morning- Sahacharadi taila Anuvasana Basti after food
Group-2 (15 Patients)- Kala Basti for 9
Day 1 - morning- Sahacharadi taila Anuvasana Basti after food
Day 2 to Day 7- Morning- Sahacharadi yapana basti in empty stomach, Afternoon- Sahacharadi taila Anuvasana after food.
Day 8 to Day 9 - morning- Sahacharadi taila Anuvasana Basti after food
)
(1) Medicine Name: Brihatyadi yapana basti, Sahacharadi yapana basti, sahacharadi taila anuvasana basti, Reference: charaka samhita siddhi sthana 12th chapter, verse- 3,4, 20-22, Ashtanga Hridaya chikitsa sthana chapter 21, verse 56, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 575(ml), Frequency: od, Duration: 9 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Married women of age between 20 to 40 years.
Subject with the features of Vandhyatwa.
Subject of Primary or Secondary Infertility.
Subject with the history of regular menstruation.
Subject with the history of Anovulation.
Subject with the history of PCOD, Hypomenorrhea, Menorrhagia, and Fibroid uterus.
Subject with the history of Habitual abortion, Spontaneous abortion, or Recurrent abortion. |
|
| ExclusionCriteria |
| Details |
Subjects with a history of Pelvic Inflammatory Disease (PID), Endometriosis, and Tubal occlusion
Subjects with any known case of benign and malignant tumors
Subjects with any known case of Polymenorrhea, Metrorrhagia, or Menometrorrhagia
Subjects who are not eligible (Ayogya) for Basti treatment
Subjects with hemoglobin percentage less than eight grams per deciliter
Systemic diseases which interfere with the course of treatment
Subjects who are not willing to give consent for the treatment
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Significant growth of Graafian follicle, ovulation followed by conception in Stree Vandhyatva with special reference to Aberrant folliculogenesis based on assessment criteria.
•Follicular study performed before and after the treatment.
•Efficacy of medicine assessed based on the size of the follicle.
•Efficacy of medicine assessed based on Ovulation.
|
After 8-10 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Generation of in- depth analyzed data on the different aspect of the disease.
Generation of data on possible unexpected drug reaction.
|
1 year |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
25/05/2025 |
| 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 - NO
|
|
Brief Summary
|
Yapana Basti is both Brihmana and Shodhana, Agnideepana, Vatanulomana, Narinam Prajatanam and Shukra Mamsa Balaprada, helps in proper functioning of Tridosha , Dhatu and Upadhatu, thereby it normalizes the function of ovaries. Brihatyadi Yapana Basti and Sahacharadi Yapana Basti are mentioned in Charaka Siddhi Sthana, Uttarabasti Siddhi Adhyaya in the context of Naarinam Prajataanam. Majority of the drugs in both the formulations have Madhura Rasa, Ushna Veerya, Guru Snigdha Guna and Madhura Vipaka helps in proper functioning of Vata Dosha there by it normalizes the function of Ovaries. Hence considered for this study. |