| CTRI Number |
CTRI/2025/01/079006 [Registered on: 20/01/2025] Trial Registered Prospectively |
| Last Modified On: |
20/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of Zandu Nityam tablet and Zandu Nityam churna |
|
Scientific Title of Study
|
Evaluation of the safety & efficacy of Zandu Nityam Tablet incomparison to Zandu Nityam Churna in the management of Malavrodha w.s.r.t. Functional Constipation : A RCT |
| 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. Pragati Ashok Katariya |
| Designation |
Professsor and Hod, dept of kayachikitsa |
| Affiliation |
Shri Dhanwantry Ayurvedic college and hospital, Chandigarh |
| Address |
Room no. 109
OPD of Kayachikitsa department,
Shri Dhanwantry ayurvedic college and hospital, sector 46-B, Chandigarh, 160047
Chandigarh CHANDIGARH 160047 India |
| Phone |
7814144288 |
| Fax |
|
| Email |
pragatidr5@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sumit Shrivastava |
| Designation |
Principal |
| Affiliation |
Shri Dhanwantry Ayurvedic college and hospital, chandigarh |
| Address |
Principal office,
Academic Block,
Shri Dhanwantry ayurvedic college and hospital, sector 46-B, Chandigarh, 160047
Chandigarh CHANDIGARH 160047 India |
| Phone |
7986502791 |
| Fax |
|
| Email |
sumitpankaj@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Vaidya Kanika Aggarwal |
| Designation |
Professor department of Panchkarma |
| Affiliation |
Shri Dhanwantry ayurvedic college and hospital, chandigarh |
| Address |
Room no. 110,
OPD of Panchkarma department,
Shri Dhanwantry ayurvedic college and hospital, sector 46-B, Chandigarh, 160047
Chandigarh CHANDIGARH 160047 India |
| Phone |
8360282161 |
| Fax |
|
| Email |
kanikaaggarwal1986@gmail.com |
|
|
Source of Monetary or Material Support
|
| Emami limited,
Emami Tower
687 Anandapur, EM Bypass
Kolkata 700107 West Bengal, INDIA |
|
|
Primary Sponsor
|
| Name |
Emami limited , Kolkata |
| Address |
Emami tower, 687. Anandapur, EM Bypass, Kolkata, 700107, West Bengal |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
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 Pragati Ashok Katariya |
Shri Dhanwantry Ayurvedic college and hospital, chandigarh |
Room no. 109
OPD of Kayachikitsa department,
Shri Dhanwantry ayurvedic college and hospital, sector 46 B, chandigarh 160047 Chandigarh CHANDIGARH |
7814144288
pragatidr5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, Shri Dhanwantry ayurvedic college and hospital chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K590||Constipation. Ayurveda Condition: MALA-APRAVRUTIHÂ (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Zandu Nityam Churna, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 10(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Ushna jala), Additional Information: - | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Zandu Nityam Tablet, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Ushna jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients of Functional constipation, fulfilling diagnostic criteria of ROME III criteria for functional constipation, Patients irrespective of sex, caste and religion, patients willing to provide informed consent |
|
| ExclusionCriteria |
| Details |
Patients not fulfilling the diagnostic criteria.
Pregnant and lactating women
Patients of other gastro-intestinal diseases like IBS etc.
patients having life threatening disorders like malignancies, renal failure, cardiac failure.
patients having other co-morbidities like hypertension, diabetes mellitus, hypothyroidism etc. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Zandu Nityam Tablet is non-inferior to Zandu Nityam Churna in improving bowel movement frequency and stool consistency
2. Zandu Nityam Tablet has a comparable safety profile to Zandu Nityam Churna |
6 months
Period required for pre-trial preparation: 45
Period which may be needed for collecting the data: 3 months
period that may be required for analyzing the data: 1 month
period that may be required for submitting final report: 15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of patient satisfaction with the treatment, including ease of use, preference for tablets vs. churna, and perceived effectiveness. |
6 months
Period required for pre-trial preparation: 45
Period which may be needed for collecting the data: 3 months
period that may be required for analyzing the data: 1 month
period that may be required for submitting final report: 15 days |
|
|
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
14/02/2025 |
| 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="0" Months="6" 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
|
BACKGROUND
Constipation is a
heterogeneous, multifactorial disorder. Patients with constipation present with
a varying set of symptoms, including infrequent bowel movements, defecatory disorders,
and hard stool consistency. The prevalence of constipation is approximately
16%, with female predominance, and increases with age. Although it is not fatal
in most cases, chronic constipation can result in decreased work productivity,
impaired quality of life, and increased healthcare costs.
Guidelines recommend a stepwise approach for the management
of constipation. After initial lifestyle modifications, bulking agents and
osmotic laxatives are recommended as first-line pharmacologic treatments.
However, more than half of patients are not sufficiently satisfied with their
treatment. Patient satisfaction with treatment varies, and alternative
conservative management is widely used by patients with constipation.
Malavrodha is a
condition caused by vitiation of Vata Dosha especially Apana Vata along with
Agnimandya. Malavrodha as a separate disease entity is not mentioned in the Ayurveda
classics, but described as either symptom or complication in association with
many diseases. Vata Prakopaka Ahara and Vihara are the prime causes of
Malavrodha. This can be understood as improper dietary habits and lifestyle and
constant mental stress that results in disturbances of Agni and Apanavata.
Agnimandya and Apana Vata Dushti are invariably present in the Samprapti of the
Vibandha along with derangement in the function of Pachaka Pitta, Avalambaka
Kapha and Samana Vata. Early intervention, dietary modifications like fiber
rich food, proper toilet training helps to relieve constipation and prevents
further complications.
Nityam churna &
Nityam Tablet are well-known Ayurvedic product being marketed in India to
overcome the symptoms of functional constipation. Both the products contains standardized
Ayurvedic ingredients. The major ingredients are Triphala, swarnapatri, eranda
taila, saunf, sanchal along with other Ayurvedic ingredients, which are well
known to have laxative properties and helps to improve intestinal movement,
maintains gut health, eases bowel movements, soothes the intestine, relives
intestinal cramps, cleanses colon and relives stomach bloating.
| Study Title: | Evaluation of the Safety & Efficacy of Zandu Nityam Tablet in comparison to Zandu Nityam churna in the management of Malavrodh w.s.r.t. functional Constipation: A RCT
| | Type of study | Drug trial –Poly herbal Ayurvedic medicines
| | Study Design | Single Centre, Randomized, Open label, control clinical trial.
| | Objective | Primary Objective To evaluate the efficacy of Zandu Nityam Tablet in comparison to Zandu Nityam Churna in the management of Malavrodha w.s.r.t. Functional Constipation Secondary Objective To validate the clinical efficacy of Zandu Nityam Tablet in comparison to Zandu Nityam Churna on the basis of scientific parameters in the patients suffering from Malavrodha w.s.r.t. functional constipation. To evaluate the safety of Zandu Nityam Tablet & Zandu Nityam Churna in the patients suffering from Malavrodha w.s.r.t. functional constipation. To compare the efficacy of Zandu Nityam Tablet with Zandu Nityam Churna | | Duration of study | 6 Month Period required for pre-trial preparation: 45 days Period which may be needed for collecting the data: 3 months Period that may be required for analyzing the data: 1 month Period that may be required for submitting final report: 15 days | | Sample size | Total 60 complete cases | |