| CTRI Number |
CTRI/2025/01/079712 [Registered on: 29/01/2025] Trial Registered Prospectively |
| Last Modified On: |
07/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Basti Therapy] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of Krishnadi churna and Madhutailik basti in PCOS |
|
Scientific Title of Study
|
Effect of Krishnadi churna and Madhutailik Basti in the management of Polycystic Ovarian Syndrome- Clinical Trial and In-silico study |
| 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 Dravya Pandey |
| Designation |
Junior Resident |
| Affiliation |
Institue of Medical Sciences Faculty of Ayurveda Banaras Hindu University |
| Address |
Department of Prasuti Tantra Faculty of Ayurveda IMS BHU Varanasi Uttar Pradesh India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
09453804545 |
| Fax |
|
| Email |
dravya0045@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Preeti Chouhan |
| Designation |
Assistant Professor |
| Affiliation |
Institute of Medical sciences Faculty of Ayurveda Banaras Hindu University |
| Address |
Department of Prasuti Tantra Faculty of Ayurveda IMS BHU Varanasi Uttar Pradesh India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9413636378 |
| Fax |
|
| Email |
drpchouhan1990@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Preeti Chouhan |
| Designation |
Assistant Professor |
| Affiliation |
Institute of Medical sciences Faculty of Ayurveda Banaras Hindu University |
| Address |
Department of Prasuti Tantra Faculty of Ayurveda IMS BHU Varanasi Uttar Pradesh India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9413636378 |
| Fax |
|
| Email |
drpchouhan1990@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Medical Sciences Banaras Hindu University, Varanasi Uttar Pradesh 221005 India |
|
|
Primary Sponsor
|
| Name |
Faculty of Ayurveda Institute of Medical Sciences BHU |
| Address |
Department of Prasuti Tantra Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University Varanasi Uttar Pradesh 221005 India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Dravya Pandey |
Sir Sunderlal Hospital BHU |
OPD No 24 Prasuti tantra OPD Department of Prasuti Tantra Indian Medicine Wing IMS BHU Varanasi Uttar Pradesh 221005 India
Varanasi
UTTAR PRADESH |
09453804545
dravya0045@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Institute of Medical Sciences Banaras Hindu University |
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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Krishnadi Churna, Reference: Charak chikitsa sthan chapter 13 verse 41 and 42, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: - | | 2 | Intervention Arm | Procedure | - | mAdhutailikabastiH, माधुतैलिकबस्तिः | (Procedure Reference: Charak siddhisthan chapter 1, Procedure details: Madhutailika Basti will be given early morning empty stomach after clearance of menses alternately with Murchhit Tila Taila Matra Basti (60ml) for 8 days consecutively for 2 cycles. A total of 8 Basti will be administered in the form of Yoga Basti (3 Niruha & 5 Matra).)
(1) Medicine Name: Madhutailik Basti, Reference: Ashtang Hriday Kalpasthan chapter 4 verse 27 and 28, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 228(ml), Frequency: od, Duration: 2 Months |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1)Female patients of Age group 16 - 40 years.
2)Patients diagnosed with PCOS as defined by Modified Rotterdam Criteria ie if any two of the following are present
(i)Clinical(Acne, hirsutism, hairloss) or Biochemical(raised total or free Testosterone ) evidence of hyperandrogenism.
(ii) Oligo-Anovulation (Oligo-amenorrhoea (cycles more than 35 days apart or less than 8 menses a year )
(iii)Polycystic Ovarian Morphology ( more than or equal to 20 follicles per ovary in either ovary, more than or equal to 10 cm ovarian volume)
3) Both married and unmarried patients
|
|
| ExclusionCriteria |
| Details |
1. Patient of age less than 16 and above the age of 40 years.
2. Patients with diagnosed cases of congenital malformation of uterus, adnexa or reproductive organs.
3. Benign and Malignant lesion of reproductive organs.
4. Endocrinal dysfunction like Thyroid Dysfunction, Adrenal Hyperplasia.
5. Women with chronic ailments (systemic diseases like TB, DM, jaundice, bronchial asthma, cardiovascular diseases, Chronic liver Disease etc.).
6. Patients with Anorectal disease like Haemorrhoids, fistula, fissures or having any history of psychological disorder.
7. Patient having Acute pelvic inflammatory disease.
8. Patient taking any hormonal therapy and history of Hormonal Contraception within 3 months prior to study , patient taking lipid lowering drugs or other drugs affecting Insulin Senstivity or Serum Androgen.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Normalization of certain parameters that include-
1)General Body Parameters
a)BMI
b)Waist Circumference
c)Hip Circumference
d)Waist Hip Ratio
2) Hormonal levels:
A) Serum FSH on day 2 or 3 of menses
B) Serum LH on day 2 or 3 of menses
C) LH/FSH ratio
D) Serum Prolactin
E) Serum TSH
F) Serum Testosterone
G) Serum AMH
3) HOMA-IR
4) USG (Pelvis) Colour Doppler : Ovarian Volume
Number and size of Dominant follicle
Uterine Artery Resistive index
5) C-reactive protein
6) Lipid Profile
7) Clinical Hyperandrogenism ( modified Ferriman-Gallway score)
8)LFT and RFT Values
|
A total of 4 follow ups at an interval of one month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in the quality of life of PCOS patients pertaining to their physical mental emotional social & behavioural well being |
A standard PCOS Questionnaire will be attempted at baseline before the start of treatment & at the end of 3 months that is after the end of treatment |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
10/02/2025 |
| 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="5" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| 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
|
Polycystic Ovarian syndrome is the most prevalent endocrinopathy affecting women in the reproductive age group which has a negative impact on several organ systems and can lead to abnormal uterine bleeding, anovulation, altered serum lipid levels, acne, acanthosis nigricans, polycystic ovaries and infertility etc According to Ayurvedic classics, the whole deranged metabolic processes distributed in PCOS is considered as Dhatwagni Vikar or Bahudoshavastha, hence Basti therapy is given which pacifies Vata Dosha which in turn causes normalization of other doshas. PCOS is often referred to as a state of chronic inflammation , henceforth Krishnadi churna described in Charak Samhita in Shavathu chikitsa is given as a trial drug whose constituents posses potent anti inflammatory properties. |